Exercise, Lung Transplantation
Conditions
Brief summary
Estimated costs, from thirty days prior to lung transplant up through six months post surgery, exceed 1 million dollars per patient and routine medical costs average approximately fifty thousand dollars per year thereafter. Prior to transplant, lung transplant recipients self restrict activity due to severe respiratory limitations, resulting in reduced muscle mass and qualitative changes in large skeletal muscles. After transplant, despite improved lung function, studies consistently report that lung recipients fail to reach predicted physical function and physical activity. Nearly seventy percent are at risk of developing hypertension within the first five years due to side effects of immunosuppression and an inactive lifestyle worsens this risk. Consequently, full benefits of transplant may not be achieved. Few studies have tested ways to engage lung recipients in self management of exercise and adopt an active lifestyle. Lung Transplant Go LTGO is a behavioral exercise intervention that provides individualized exercise training integrated with behavioral coaching delivered in the recipient's home. Exercise training will focus on assisting lung recipients to learn and practice exercises to reverse muscle conditioning. Behavioral coaching will assist them to develop the skills to self manage physical activity in daily life and maintain this as a sustained habit using strategies that include incremental goal setting, self-monitoring, feedback and problem solving.
Detailed description
This is a two-group randomized controlled trial (RCT) comparing LTGO to enhanced usual care (EUC). Based on estimations using a published RCT, effect sizes measured by Cohen's d ranged from 0.64 to 1.45 across outcome variables (i.e., 0.64 for physical function; 0.73-0.99 for physical activity; and 1.19 and1.45 for systolic and diastolic BP with 80% power, α=0.05). With a final sample of 80 subjects (40 per group) we will have 80% power to detect an effect size as small as 0.64 (α=0.05, two-tailed) from independent sample t-test for measures of physical function, physical activity and hypertension onset/control. Recruiting and randomizing 112 individuals (56 in LTGO & 56 in EUC) will allow for up to 30% attrition. Participants will be randomized to LTGO or EUC (1:1). The biostatistician will randomize participants using a blocked randomization scheme, stratified by sex (male vs. female) and length of hospital stay (≤2 wks vs.\>2 wks). The block size (2 or 4) will be randomly selected to prevent prediction of group assignment. An intention-to-treat (ITT) approach will be used. All subjects will be analyzed in the group to which they were randomly assigned, regardless of adherence to the protocol, treatment received, and/or withdrawal from the protocol. Endorsed by international regulatory guidelines, the ITT approach is widely used in RCT because it minimizes the potential for the introduction of biases into data analysis and maintains prognostic balance generated from original random treatment allocation. Although the ITT approach is recommended for efficacy analysis in RCTs, the sensitivity of the results assumes that ITT will be explored using information collected regarding fidelity and dosage (e.g., number of sessions completed).
Interventions
BEHAVIORALLTGO-Home Based Exercise
The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, Versatile and Integrated System for Tele-Rehabilitation (VISYTER)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement
BEHAVIORALEnhanced Usual Care
Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Sponsors
National Institute of Nursing Research (NINR)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
There will be two groups. The research study that will compare two methods of self-managing exercise after receiving a lung transplant. These methods are a home-based exercise program plus self-monitoring or self-monitoring alone. The investigator would also like to collect information about the patients health and ability to exercise, and the amount of physical activity the participants do per day. The length of the study will be 6 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older -\>4 weeks after the participant had lung transplant surgery * Discharged from the hospital after your lung transplant surgery * MD report of difficulty walking ¼ mile or climbing 10 steps without resting * Medical monitor approves patient eligibility for participation
Exclusion criteria
* concurrent participation in a formal exercise program, e.g., pulmonary rehabilitation, during the active eligible study period with no plans to stop formal exercise * having other chronic conditions that may severely limit participation in exercise training, i.e., cardiac, musculoskeletal or cognitive impairments * does not have home internet or smart device with Bluetooth capabilities * medical issue precluding participation * declining to be asked screening questions, or declining an introduction to the research team to hear about research * greater than 18 months post-transplant hospital discharge (time/scheduling delays, transportation issues, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months. | Baseline and 6 months. | The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (6 month score minus baseline score). |
| Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months. | Baseline and 6 months | Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 6 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (6 month score minus baseline score). |
| Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months. | Baseline and 3 months. | The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (3 month score minus baseline score). |
| Physical Function- Balance: Change in Berg Balance at Month 3 | Baseline and 3 months. | Balance was measured as the change in Berg Balance Score at baseline and 3 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56. Higher scores indicate a better outcome. Change = (3 month score minus baseline score). |
| Physical Function- Walking: Change in Average Steps Per Day at Month 3 | Baseline and 3 months | Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 3 months. Minimum = 0, no upper limit. Higher scores mean a better outcome. Change = (3 month score minus baseline score). |
| Physical Function- Walking: Change in Average Steps Per Day at Month 6 | Baseline and 6 months | Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 6 months. Minimum = 0, no upper limit. Higher scores indicate a better outcome. Change = (6 month score minus baseline score). |
| Physical Function- Balance: Change From Baseline to 6 Months | Baseline and 6 months | Balance was measured as the change in Berg Balance Score at baseline and 6 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56. Higher scores indicate a better outcome. Change = (6 month score minus baseline score). |
| Physical Function-Lower Body Strength: Change From Baseline to 3 Months | Baseline and 3 months. | Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 3 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On Go, the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score =0 with no upper limit. More repetitions indicate better outcome. Change = (3 month score minus baseline score). |
| Physical Function-Lower Body Strength: Change From Baseline to 6 Months | Baseline and 6 months. | Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 6 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On Go, the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score = 0 with no upper limit. More repetitions indicate better outcome. Change = (6 month score minus baseline score). |
| Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months. | Baseline and 3 months. | Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 3 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (3 month score minus baseline score). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Control-Change From Baseline to 6 Months | Baseline and 6 months. | Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 6 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 6 months. A higher count indicates better outcome. |
| Blood Pressure Control-Change From Baseline to 3months | Baseline and 3 months | Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 3 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 3 months. A higher count indicates better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LTGO-Home Based Exercise The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.
LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.
Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement | 44 |
| Enhanced Usual Care Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. | 44 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 0 |
Baseline characteristics
| Characteristic | LTGO-Home Based Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 54.89 years STANDARD_DEVIATION 14.01 | 57.93 years STANDARD_DEVIATION 11.79 | 56.41 years STANDARD_DEVIATION 12.96 |
| Average steps per day | 3169.62 Average steps per day STANDARD_DEVIATION 2841.43 | 3507.14 Average steps per day STANDARD_DEVIATION 2535.84 | 3338.16 Average steps per day STANDARD_DEVIATION 2682.2 |
| Berg Balance | 53.69 units on a scale STANDARD_DEVIATION 2.76 | 52.71 units on a scale STANDARD_DEVIATION 4.3 | 53.21 units on a scale STANDARD_DEVIATION 3.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 42 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Lower body strength | 9.64 Repetitions STANDARD_DEVIATION 2.89 | 9.78 Repetitions STANDARD_DEVIATION 3.57 | 9.70 Repetitions STANDARD_DEVIATION 3.21 |
| Minutes per day in Moderate and Vigorous Physical Activity | 11.5 Minutes per day STANDARD_DEVIATION 13.43 | 9.26 Minutes per day STANDARD_DEVIATION 9.35 | 10.12 Minutes per day STANDARD_DEVIATION 11.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 36 Participants | 42 Participants | 78 Participants |
| Respiratory-related quality of life St George Respiratory Questionnaire | 31.65 units on a scale STANDARD_DEVIATION 18.86 | 31.16 units on a scale STANDARD_DEVIATION 19.89 | 31.40 units on a scale STANDARD_DEVIATION 19.27 |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Male | 23 Participants | 25 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months.
The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (3 month score minus baseline score).
Time frame: Baseline and 3 months.
Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of MVPA between baseline and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months. | 2.18 minutes per day | Standard Deviation 7.37 |
| Enhanced Usual Care | Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months. | 1.17 minutes per day | Standard Deviation 13 |
p-value: 0.7073Wilcoxon (Mann-Whitney)
Primary
Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months.
The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (6 month score minus baseline score).
Time frame: Baseline and 6 months.
Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of MVPA between baseline and 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months. | 2.38 minutes per day | Standard Deviation 9.99 |
| Enhanced Usual Care | Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months. | 6.53 minutes per day | Standard Deviation 21.6 |
p-value: 0.313Wilcoxon (Mann-Whitney)
Primary
Physical Function- Balance: Change From Baseline to 6 Months
Balance was measured as the change in Berg Balance Score at baseline and 6 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56. Higher scores indicate a better outcome. Change = (6 month score minus baseline score).
Time frame: Baseline and 6 months
Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of Berg Balance between baseline and 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Function- Balance: Change From Baseline to 6 Months | 1.71 units on a scale | Standard Deviation 3.29 |
| Enhanced Usual Care | Physical Function- Balance: Change From Baseline to 6 Months | 0.74 units on a scale | Standard Deviation 1.73 |
p-value: 0.81Wilcoxon (Mann-Whitney)
Primary
Physical Function- Balance: Change in Berg Balance at Month 3
Balance was measured as the change in Berg Balance Score at baseline and 3 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56. Higher scores indicate a better outcome. Change = (3 month score minus baseline score).
Time frame: Baseline and 3 months.
Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of Berg Balance between baseline and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Function- Balance: Change in Berg Balance at Month 3 | 0.48 units on a scale | Standard Deviation 1.96 |
| Enhanced Usual Care | Physical Function- Balance: Change in Berg Balance at Month 3 | 0.67 units on a scale | Standard Deviation 1.67 |
p-value: 0.3Wilcoxon (Mann-Whitney)
Primary
Physical Function-Lower Body Strength: Change From Baseline to 3 Months
Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 3 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On Go, the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score =0 with no upper limit. More repetitions indicate better outcome. Change = (3 month score minus baseline score).
Time frame: Baseline and 3 months.
Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of 30-Second Chair Stand Test between baseline and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Function-Lower Body Strength: Change From Baseline to 3 Months | 0.964 repetitiions | Standard Deviation 2.03 |
| Enhanced Usual Care | Physical Function-Lower Body Strength: Change From Baseline to 3 Months | 0.314 repetitiions | Standard Deviation 2.18 |
p-value: 0.2262Wilcoxon (Mann-Whitney)
Primary
Physical Function-Lower Body Strength: Change From Baseline to 6 Months
Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 6 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On Go, the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score = 0 with no upper limit. More repetitions indicate better outcome. Change = (6 month score minus baseline score).
Time frame: Baseline and 6 months.
Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of 30-Second Chair Stand Test between baseline and 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Function-Lower Body Strength: Change From Baseline to 6 Months | 1.5 repetitions | Standard Deviation 2.53 |
| Enhanced Usual Care | Physical Function-Lower Body Strength: Change From Baseline to 6 Months | 1.11 repetitions | Standard Deviation 3.29 |
p-value: 0.59Wilcoxon (Mann-Whitney)
Primary
Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months.
Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 3 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (3 month score minus baseline score).
Time frame: Baseline and 3 months.
Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of SGRQ between baseline and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months. | -4.64 units on a scale | Standard Deviation 9.29 |
| Enhanced Usual Care | Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months. | -6.45 units on a scale | Standard Deviation 11.56 |
p-value: 0.26Wilcoxon (Mann-Whitney)
Primary
Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months.
Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 6 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (6 month score minus baseline score).
Time frame: Baseline and 6 months
Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of respiratory-related quality of life between baseline and 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months. | -6.33 units on a scale | Standard Deviation 11.26 |
| Enhanced Usual Care | Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months. | -6.83 units on a scale | Standard Deviation 8.38 |
p-value: 0.78Wilcoxon (Mann-Whitney)
Primary
Physical Function- Walking: Change in Average Steps Per Day at Month 3
Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 3 months. Minimum = 0, no upper limit. Higher scores mean a better outcome. Change = (3 month score minus baseline score).
Time frame: Baseline and 3 months
Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of average steps per day between baseline and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Function- Walking: Change in Average Steps Per Day at Month 3 | 460 average steps per day | Standard Deviation 3410 |
| Enhanced Usual Care | Physical Function- Walking: Change in Average Steps Per Day at Month 3 | 352 average steps per day | Standard Deviation 2470 |
p-value: 0.8793Wilcoxon (Mann-Whitney)
Primary
Physical Function- Walking: Change in Average Steps Per Day at Month 6
Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 6 months. Minimum = 0, no upper limit. Higher scores indicate a better outcome. Change = (6 month score minus baseline score).
Time frame: Baseline and 6 months
Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of average steps per day between baseline and 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LTGO-Home Based Exercise | Physical Function- Walking: Change in Average Steps Per Day at Month 6 | 445 average steps per day | Standard Deviation 2310 |
| Enhanced Usual Care | Physical Function- Walking: Change in Average Steps Per Day at Month 6 | 405 average steps per day | Standard Deviation 3570 |
p-value: 0.9597Wilcoxon (Mann-Whitney)
Secondary
Blood Pressure Control-Change From Baseline to 3months
Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 3 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 3 months. A higher count indicates better outcome.
Time frame: Baseline and 3 months
Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in counts of participants with the same or improved stage of hypertension between baseline and 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LTGO-Home Based Exercise | Blood Pressure Control-Change From Baseline to 3months | 30 Participants |
| Enhanced Usual Care | Blood Pressure Control-Change From Baseline to 3months | 31 Participants |
p-value: 0.91Chi-squared
Secondary
Blood Pressure Control-Change From Baseline to 6 Months
Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 6 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 6 months. A higher count indicates better outcome.
Time frame: Baseline and 6 months.
Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in counts of participants with the same or improved stage of hypertension between baseline and 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LTGO-Home Based Exercise | Blood Pressure Control-Change From Baseline to 6 Months | 30 Participants |
| Enhanced Usual Care | Blood Pressure Control-Change From Baseline to 6 Months | 24 Participants |
p-value: 0.72Chi-squared