Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Yoga, Pilates, Telerehabilitation, Physical activity
Brief summary
The purpose of this study is to compare the effects of two delivery models of an evidence-based complementary alternative medicine (CAM) program that combines neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM). Participants will be randomly assigned to one of these two groups. \*\*On March 16th, 2020, the University of Alabama at Birmingham halted all onsite non-essential research in response to the Covid-19 pandemic. Since then, the study has begun to conduct all testing remotely through videoconferencing technology. In addition, another study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue the 12-week program delivery for newly recruited participants via videoconferencing technology.\*\*
Detailed description
There are few primary care and multiple sclerosis (MS) clinics that provide full exercise and rehabilitation services for patients with MS, especially in mostly rural, low-income areas such as Alabama, Mississippi, and Tennessee. Telerehabilitation, or the delivery of rehabilitation services over the telephone and/or the Internet, can help fill service gaps for underserved MS patient populations in this region. The proposed study will determine if our evidence-based rehabilitation and exercise program produces similar health outcomes when delivered in clinic or at home, using pre-loaded tablets and Interactive Voice Response (IVR) system technology among 759 participants with MS from 40 clinics across Alabama, Mississippi, and Tennessee. \*\*In response to the Covid-19 pandemic, the study aims to recruit 74 participants with MS into the rDirectCAM, where the 12-week program is delivered in real-time via videoconferencing technology. The rDirectCAM will determine if a telehealth rehabilitation program can have a similar effect as when the program is offered in person.\*\* The outcomes that we hope to achieve through the proposed rehabilitation and exercise program, referred to as complementary alternative medicine, are improved physical activity, decreased pain and fatigue, and quality of life. We also seek to improve attitudes and behaviors related to physical activity, such as outcome expectations for physical activity, social support from family and friends for physical activity, self-efficacy (i.e., confidence in one's ability to be active), and self-regulation (i.e., setting exercise goals). We will examine the variation in outcomes by patient characteristics such as age and severity of disability to determine for whom the intervention is effective. This project is important to patients with MS because it seeks to reduce their barriers to receiving exercise treatment and increase the convenience and appeal of such programs through technology. Furthermore, findings and resources from this study will be quickly provided to MS patients and clinicians across the United States (e.g., via training webinars through our National Center on Health, Physical Activity, and Disability \[NCHPAD\]) and thereby improve the quality and reach of exercise treatment for patients with MS. The patient and stakeholder partners include MS patients, caretakers, and clinicians, who have been actively guiding the development of this project. In stakeholder meetings, members have provided insight into exercise treatment needs and preferences (e.g., individually tailored approaches that account for varying levels of mobility); outcomes of interest to the patient population (e.g., pain, fatigue, quality of life); and strategies for engaging/motivating participants with MS who may be discouraged and experiencing fatigue and pain (e.g., IVR calls and feedback). Moreover, their ongoing program satisfaction feedback will be important to our recruitment and retention success. Finally, the stakeholders will help make this project successful by continuing to emphasize the importance of long-term gains in health outcomes and promote (through NCHPAD) the sustainability of the program.
Interventions
BEHAVIORALDirectCAM
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
BEHAVIORALTeleCAM
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
BEHAVIORALrDirectCAM
The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
Sponsors
Patient-Centered Outcomes Research Institute
Alabama Neurology Associates, PC
Lakeshore Foundation
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Physician permission to participate in the study * Mild to moderate disability (i.e., ambulate with/without assistive device, Patient-Determined Disease Steps \[PDDS\] 0 - 7 * Able to use arms/legs for exercise
Exclusion criteria
* Significant visual acuity that prevents seeing a tablet screen to follow home exercise program * Cardiovascular disease event within the last six months, several pulmonary disease, and/or renal failure * Active pressure ulcers * Currently pregnant * Within 30 days of receiving a rehabilitation program * Already meeting physical activity guidelines (GLTEQ \> 24)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Fatigue was measured by Modified Fatigue Impact Scale (MFIS). The total score range is 0 to 84, with a higher score indicating more fatigue. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Physical Activity | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ). The score ranges from 0 to 119, with higher scores indicating more physical activity. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Quality of Life (Mental Component) | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | The mental component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Mental Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the mental component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Quality of Life (Physical Component) | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | The physical component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Physical Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the physical component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Pain | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Pain was measured by 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100, with a higher score indicating less pain. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for rDirectCAM reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Grip Strength | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Grip strength was measured using a hand-held dynamometer. The higher score measured in pounds (lbs) indicates better grip strength. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Balance (Five Times Site to Stand) | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Balance was measured by the Five Times Site to Stand (FTSTS) test. Less time (in seconds) used to complete the FTSTS test indicates better balance. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Endurance | 48 weeks for DirectCAM and TeleCAM. | Endurance was measured using the 6-Minute Walk Test (6MWT). More distance traveled (meters) within the 6 minutes indicates better walking endurance. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section. |
| Change in Gait (Timed Up and Go) | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Gait was measured by the Timed Up and Go (TUG) test. Less time (in seconds) taken to complete the TUG test indicates better gait. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Gait (Timed 25-Foot Walk) | 48 weeks for DirectCAM and TeleCAM. | Gait was measured using the Timed 25-Foot Walk (T25FW) test. Less time taken to complete the T25FW test indicates better gait. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section. |
| Change in Balance (Berg Balance Scale) | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Balance was measured using the Berg Balance Scale (BBS). The score ranges from 0 to 56, with a lower score indicating a higher risk of falling and a higher score indicating better functional mobility. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for TeleCAM and rDirectCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise Self-Regulation | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Exercise self-regulation was measured by the Exercise Goal-Setting Scale. The total score ranges from 10 to 50, with a higher score indicates better or more effective goal-setting behaviors in relation to exercise. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Social Support for Exercise | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Social support for exercise was measured by the Social Provisions Scale. The score ranges from 24 (1 point for each item) to 96 (4 points for each item), with higher scores indicate higher perceived social support and lower scores suggest lower perceived social support. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Exercise Self-Efficacy | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Exercise self-efficacy was measured by the Exercise Self-Efficacy Scale. The total score ranges from 0 to 100, with higher scores indicate better exercise self-efficacy. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section. |
| Change in Outcome Expectations for Exercise | 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM. | Outcome expectations for exercise was measured by the Multidimensional Outcome Expectations for Exercise Scale (MOEES). The total score ranges from 15 to 75, with a higher score on the MOEES reflects greater positive expectations regarding the outcomes of exercise across the three domains (physical, social, and self-evaluative). The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and rDirectCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DirectCAM The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts. | 382 |
| TeleCAM The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos. | 377 |
| rDirectCAM The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts. | 74 |
| Total | 833 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 12-Month Follow-Up | Did not complete test | 40 | 0 | 0 |
| 12-Month Follow-Up | Lost to Follow-up | 18 | 22 | 0 |
| 12-Month Follow-Up | Withdrawal by Subject | 3 | 2 | 0 |
| 6-Month Follow-Up | Did not complete test | 53 | 25 | 7 |
| 6-Month Follow-Up | Lost to Follow-up | 18 | 8 | 2 |
| 6-Month Follow-Up | Withdrawal by Subject | 4 | 8 | 0 |
| Baseline | Lost to Follow-up | 22 | 25 | 0 |
| Baseline | Withdrawal by Subject | 21 | 10 | 0 |
| Post-Intervention Follow-Up (3 Months) | Did not complete test | 33 | 22 | 2 |
| Post-Intervention Follow-Up (3 Months) | Lost to Follow-up | 34 | 38 | 4 |
| Post-Intervention Follow-Up (3 Months) | Withdrawal by Subject | 26 | 21 | 1 |
Baseline characteristics
| Characteristic | DirectCAM | TeleCAM | rDirectCAM | Total |
|---|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 10.3 | 50.0 years STANDARD_DEVIATION 11 | 49.3 years STANDARD_DEVIATION 11.7 | 50.1 years STANDARD_DEVIATION 10.8 |
| Balance measured by Berg Balance Scale | 44.16 units on a scale STANDARD_DEVIATION 14.27 | 47.37 units on a scale STANDARD_DEVIATION 12.18 | 52.07 units on a scale STANDARD_DEVIATION 7.26 | 46.10 units on a scale STANDARD_DEVIATION 13.18 |
| Balance measured by Five Times Sit to Stand | 19.55 seconds STANDARD_DEVIATION 12.48 | 17.88 seconds STANDARD_DEVIATION 9.25 | 15.79 seconds STANDARD_DEVIATION 6.68 | 18.53 seconds STANDARD_DEVIATION 10.8 |
| Endurance measured by Six Minute Walk Test | 296.98 meters STANDARD_DEVIATION 127.19 | 317.74 meters STANDARD_DEVIATION 124.48 | — | 307.38 meters STANDARD_DEVIATION 126.18 |
| Exercise Self Efficacy measured by Exercise Self-Efficacy Scale | 80.90 units on a scale STANDARD_DEVIATION 16.71 | 91.14 units on a scale STANDARD_DEVIATION 14.27 | 87.56 units on a scale STANDARD_DEVIATION 18.08 | 90.28 units on a scale STANDARD_DEVIATION 15.78 |
| Exercise Self Regulation measured by Exercise Goal-Setting Scale | 23.28 units on a scale STANDARD_DEVIATION 10.06 | 23.47 units on a scale STANDARD_DEVIATION 9.45 | 20.29 units on a scale STANDARD_DEVIATION 9.44 | 23.12 units on a scale STANDARD_DEVIATION 9.76 |
| Fatigue measured by Modified Fatigue impact Scale | 43.64 units on a scale STANDARD_DEVIATION 16.8 | 42.84 units on a scale STANDARD_DEVIATION 16.98 | 40.19 units on a scale STANDARD_DEVIATION 19.5 | 42.99 units on a scale STANDARD_DEVIATION 17.12 |
| Gait measured by Timed 25-Foot Walk Test | 11.72 seconds STANDARD_DEVIATION 27.53 | 8.38 seconds STANDARD_DEVIATION 9.62 | — | 10.06 seconds STANDARD_DEVIATION 20.7 |
| Gait measured by Timed Up and Go | 16.89 seconds STANDARD_DEVIATION 25.06 | 14.50 seconds STANDARD_DEVIATION 21.05 | 9.82 seconds STANDARD_DEVIATION 5.52 | 15.37 seconds STANDARD_DEVIATION 22.58 |
| Grip strength measured by hand dynamometer | 50.86 pounds STANDARD_DEVIATION 20.58 | 51.41 pounds STANDARD_DEVIATION 19.45 | 49.13 pounds STANDARD_DEVIATION 19.97 | 51.01 pounds STANDARD_DEVIATION 20.01 |
| Outcome Expectations for Exercise measured by Multidimensional Outcome Expectations for Exercise | 60.16 units on a scale STANDARD_DEVIATION 7.39 | 60.51 units on a scale STANDARD_DEVIATION 7.54 | 59.22 units on a scale STANDARD_DEVIATION 6.48 | 60.25 units on a scale STANDARD_DEVIATION 7.39 |
| Pain measured by 36-Item Short Form Survey (SF-36) Pain domain | 56.84 units on a scale STANDARD_DEVIATION 23.88 | 58.64 units on a scale STANDARD_DEVIATION 24.62 | 60.70 units on a scale STANDARD_DEVIATION 25.85 | 57.98 units on a scale STANDARD_DEVIATION 24.38 |
| Physical activity measured by Godin Leisure Time Exercise Score | 14.16 units on a scale STANDARD_DEVIATION 16.56 | 17.72 units on a scale STANDARD_DEVIATION 55.7 | 3.16 units on a scale STANDARD_DEVIATION 3.73 | 14.75 units on a scale STANDARD_DEVIATION 39.57 |
| Quality of life measured by 36-Item Short Form Survey (SF-36) mental component score | 42.77 units on a scale STANDARD_DEVIATION 14.78 | 43.05 units on a scale STANDARD_DEVIATION 14.67 | 41.71 units on a scale STANDARD_DEVIATION 14.94 | 42.80 units on a scale STANDARD_DEVIATION 14.73 |
| Quality of life measured by 36-Item Short Form Survey (SF-36) physical component score | 35.03 units on a scale STANDARD_DEVIATION 11.3 | 35.80 units on a scale STANDARD_DEVIATION 11.21 | 39.30 units on a scale STANDARD_DEVIATION 11.43 | 35.75 units on a scale STANDARD_DEVIATION 11.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 94 Participants | 86 Participants | 20 Participants | 200 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 6 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 6 Participants | 1 Participants | 14 Participants |
| Race (NIH/OMB) White | 278 Participants | 278 Participants | 53 Participants | 609 Participants |
| Region of Enrollment United States | 382 participants | 377 participants | 74 participants | 833 participants |
| Sex: Female, Male Female | 341 Participants | 335 Participants | 62 Participants | 738 Participants |
| Sex: Female, Male Male | 41 Participants | 42 Participants | 12 Participants | 95 Participants |
| Social Support for Exercise measured by Social Provisions Scale | 12.39 units on a scale STANDARD_DEVIATION 2.12 | 12.27 units on a scale STANDARD_DEVIATION 2.06 | 15.65 units on a scale STANDARD_DEVIATION 1.93 | 12.61 units on a scale STANDARD_DEVIATION 2.27 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 425 | 0 / 412 | 0 / 74 |
| other Total, other adverse events | 0 / 425 | 0 / 412 | 0 / 74 |
| serious Total, serious adverse events | 0 / 425 | 2 / 412 | 0 / 74 |
Outcome results
Primary
Change in Fatigue
Fatigue was measured by Modified Fatigue Impact Scale (MFIS). The total score range is 0 to 84, with a higher score indicating more fatigue. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Fatigue | -2.57 score on a scale |
| TeleCAM | Change in Fatigue | -3.58 score on a scale |
| rDirectCAM | Change in Fatigue | -1.36 score on a scale |
Primary
Change in Pain
Pain was measured by 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100, with a higher score indicating less pain. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for rDirectCAM reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Pain | 1.64 score on a scale |
| TeleCAM | Change in Pain | 1.53 score on a scale |
| rDirectCAM | Change in Pain | -2.12 score on a scale |
Primary
Change in Physical Activity
Measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ). The score ranges from 0 to 119, with higher scores indicating more physical activity. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Physical Activity | 3.74 score on a scale |
| TeleCAM | Change in Physical Activity | 6.46 score on a scale |
| rDirectCAM | Change in Physical Activity | 3.13 score on a scale |
Primary
Change in Quality of Life (Mental Component)
The mental component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Mental Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the mental component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Quality of Life (Mental Component) | 0.42 score on a scale |
| TeleCAM | Change in Quality of Life (Mental Component) | 1.10 score on a scale |
| rDirectCAM | Change in Quality of Life (Mental Component) | -1.09 score on a scale |
Primary
Change in Quality of Life (Physical Component)
The physical component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Physical Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the physical component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Quality of Life (Physical Component) | 1.34 score on a scale |
| TeleCAM | Change in Quality of Life (Physical Component) | 1.86 score on a scale |
| rDirectCAM | Change in Quality of Life (Physical Component) | 0.70 score on a scale |
Secondary
Change in Balance (Berg Balance Scale)
Balance was measured using the Berg Balance Scale (BBS). The score ranges from 0 to 56, with a lower score indicating a higher risk of falling and a higher score indicating better functional mobility. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for TeleCAM and rDirectCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Balance (Berg Balance Scale) | 3.67 score on a scale |
| TeleCAM | Change in Balance (Berg Balance Scale) | 1.56 score on a scale |
| rDirectCAM | Change in Balance (Berg Balance Scale) | 1.93 score on a scale |
Secondary
Change in Balance (Five Times Site to Stand)
Balance was measured by the Five Times Site to Stand (FTSTS) test. Less time (in seconds) used to complete the FTSTS test indicates better balance. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Balance (Five Times Site to Stand) | -3.33 seconds |
| TeleCAM | Change in Balance (Five Times Site to Stand) | -2.28 seconds |
| rDirectCAM | Change in Balance (Five Times Site to Stand) | -2.45 seconds |
Secondary
Change in Endurance
Endurance was measured using the 6-Minute Walk Test (6MWT). More distance traveled (meters) within the 6 minutes indicates better walking endurance. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM.
Population: The Six-Minute Walk test was not assessed for participants in the rDirectCAM arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Endurance | 28.30 meters |
| TeleCAM | Change in Endurance | 23.04 meters |
Secondary
Change in Gait (Timed 25-Foot Walk)
Gait was measured using the Timed 25-Foot Walk (T25FW) test. Less time taken to complete the T25FW test indicates better gait. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM.
Population: The Time 25-foot Walk was not assessed among the rDirectCAM arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Gait (Timed 25-Foot Walk) | -0.86 seconds |
| TeleCAM | Change in Gait (Timed 25-Foot Walk) | 0.48 seconds |
Secondary
Change in Gait (Timed Up and Go)
Gait was measured by the Timed Up and Go (TUG) test. Less time (in seconds) taken to complete the TUG test indicates better gait. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Gait (Timed Up and Go) | -2.24 seconds |
| TeleCAM | Change in Gait (Timed Up and Go) | -1.20 seconds |
| rDirectCAM | Change in Gait (Timed Up and Go) | -1.72 seconds |
Secondary
Change in Grip Strength
Grip strength was measured using a hand-held dynamometer. The higher score measured in pounds (lbs) indicates better grip strength. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Grip Strength | 3.11 lbs |
| TeleCAM | Change in Grip Strength | 2.68 lbs |
| rDirectCAM | Change in Grip Strength | 4.35 lbs |
Other Pre-specified
Change in Exercise Self-Efficacy
Exercise self-efficacy was measured by the Exercise Self-Efficacy Scale. The total score ranges from 0 to 100, with higher scores indicate better exercise self-efficacy. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Exercise Self-Efficacy | -27.0 score on a scale |
| TeleCAM | Change in Exercise Self-Efficacy | -26.98 score on a scale |
| rDirectCAM | Change in Exercise Self-Efficacy | -4.41 score on a scale |
Other Pre-specified
Change in Exercise Self-Regulation
Exercise self-regulation was measured by the Exercise Goal-Setting Scale. The total score ranges from 10 to 50, with a higher score indicates better or more effective goal-setting behaviors in relation to exercise. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Exercise Self-Regulation | 0.46 score on a scale |
| TeleCAM | Change in Exercise Self-Regulation | 3.63 score on a scale |
| rDirectCAM | Change in Exercise Self-Regulation | 3.71 score on a scale |
Other Pre-specified
Change in Outcome Expectations for Exercise
Outcome expectations for exercise was measured by the Multidimensional Outcome Expectations for Exercise Scale (MOEES). The total score ranges from 15 to 75, with a higher score on the MOEES reflects greater positive expectations regarding the outcomes of exercise across the three domains (physical, social, and self-evaluative). The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and rDirectCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Outcome Expectations for Exercise | -1.00 score on a scale |
| TeleCAM | Change in Outcome Expectations for Exercise | -0.21 score on a scale |
| rDirectCAM | Change in Outcome Expectations for Exercise | -0.48 score on a scale |
Other Pre-specified
Change in Social Support for Exercise
Social support for exercise was measured by the Social Provisions Scale. The score ranges from 24 (1 point for each item) to 96 (4 points for each item), with higher scores indicate higher perceived social support and lower scores suggest lower perceived social support. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Time frame: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DirectCAM | Change in Social Support for Exercise | 1.24 score on a scale |
| TeleCAM | Change in Social Support for Exercise | 1.38 score on a scale |
| rDirectCAM | Change in Social Support for Exercise | 0.33 score on a scale |