Arthritis, Cancer, Cardiovascular Diseases, Chronic Lung Disease, Congestive Heart Failure, Diabetes, Frailty, Hypertension, Kidney Diseases, Obesity, Osteoporosis, Stroke
Conditions
Keywords
remote delivery, exercise, pre-frail, nutrition, pilot study
Brief summary
Sufficient muscle strength helps to get out of a chair and can prevent falls. Up to 30% of older adults experience age-related loss of muscle strength, which can lead to frailty and health instability. Exercise helps to build muscle, maintain bone density and prevent chronic disease, especially during the aging process. However, more than 75% of Canadian adults ≥18 years of age are not meeting physical activity guidelines. In addition, it is known that malnutrition, including low protein intake, may lead to poor physical function. While there are services to support exercise and nutrition, barriers to implementing them persist. The COVID-19 pandemic has exacerbated the potential for physical inactivity, malnutrition, and loneliness among older adults, especially those with pre-existing health or mobility impairments. Now and in future, alternate ways to promote exercise and proper nutrition to the most vulnerable are needed. The investigators propose to adapt MoveStrong, an 8-week education program combining functional and balance training with strategies to increase protein intake. The program was co-developed with patient advocates, Osteoporosis Canada, the YMCA, Community Support Connections and others. MoveStrong was delivered by telephone or web conference to older adults in their homes, using mailed program instructions, 1-on-1 training sessions through Physitrack®, as well as online nutrition Q&A sessions and group discussion sessions over Microsoft® Teams. The primary aim of this study was to assess feasibility and acceptability of a remote model as determined by recruitment (≥ 25 people in 3 months), retention (≥80%), adherence of (70%) and participant experience.
Detailed description
MoveStrong at Home is an 8-week pilot study with a 4-week follow-up. The primary research question pertains to the feasibility of implementation, defined by recruitment (number of participants recruited), retention (number retained at follow up), and adherence (percentage of exercise and nutrition sessions completed) and participant experience. The criteria for success included recruitment of 8 participants per month (up to a total of 25 participants in 3 months), retention of ≥80% at follow-up, and adherence of ≥70% across all exercise and nutrition sessions. For secondary outcomes, the investigators assessed the effects of MoveStrong at Home on physical activity, fatigue, mental health and social isolation, quality of life, as well as protein/energy intake via telephone at baseline, post intervention and at follow-up. The following questionnaires were used: Physical Activity Scale for the Elderly; Centre for Epidemiologic Studies Depression Scale-fatigue questions; Warwick-Edinburgh Mental Well-being Scale; EQ5D5L20; and the Automated Self-Administered 24-Hour Dietary Assessment Tool (via interview). Physical function was assessed at baseline, post intervention and at follow-up using adapted and self-administered versions of the Short Performance Physical Battery balance test and the 30-second chair stand test. Qualitative exit and follow-up interviews were used to capture participant experience and identify barriers and facilitators to implementation and maintenance. The investigators monitored falls and adverse events throughout the study. The investigators recruited participants in two phases. The investigators recruited 9 participants between October 5th and October 23rd, 2020 to begin the intervention together by November 2020. Participants recruited after that date participated in screening and assessments between November 2020 and January 2021, and began the intervention in January 2021. The investigators considered making modifications to the protocol to address any challenges that arose during delivery with the first phase of participants. Investigators over recruited by 5 participants to account for possible dropouts. Each participant started the intervention with two 1-on-1 sessions on non-consecutive days (Monday to Friday) and completed the third session on their own. As progress is made, participants continued to receive a 1-on-1 session each week and completed two sessions independently. If a participant was unable to attend a 1-on-1 session due to a prior commitment, illness, or injury, a make-up session was scheduled for the same week or following week as necessary. In addition, individuals participated in three dietitian-led virtual group Q&A sessions to review content from the booklet and videos, as well as discuss more personalized strategies to increase protein intake. The dietitian considered the cost of preparing high-protein foods and the accessibility of these foods during a time of physical distancing. 60-minute small group seminars (5-10 participants) occurred on weeks 2, 4, and 6 (Wednesday). An optional group discussion session that focused on behaviour change techniques took place on weeks 3, 5 & 7 (Wednesday). The intention was to foster a sense of community and allow participants to share their experiences with one another. These sessions did not count toward adherence. The goal of the investigators was not to test the efficacy of exercise, but to evaluate the implementation of a scalable and sustainable models to promote exercise at home or in the community.
Interventions
OTHERExercise program
Participants received two 1-on-1 exercise sessions per week to start. Each session lasted 30 minutes. As progress was made, participants were encouraged to exercise independently outside the structured sessions while continuing to receive a 1-on-1 session each week. The individualized exercises were aligned with functional movements to promote personal relevance: balance, pull, squat, push, hinge, lift & carry and calf raise.
OTHERNutrition education
Participants received a nutrition education booklet and had access to five online videos that correspond to key topics in the booklet (reading nutrition labels, types of protein, foods containing protein, incorporating protein into meals, spreading protein in meals throughout the day). Participants attended three 60-minute nutrition Q&A sessions led by a dietitian, where the group reviewed content from the booklet and videos, and discussed personalized strategies to increase protein intake.
Sponsors
University of Waterloo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is an 8-week feasibility study with a 4-week follow-up. Time series design. Note: 6-month follow-up was optional and exploratory in nature.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has at least one of the following chronic conditions: arthritis, cancer (other than minor skin cancer), cardiovascular disease, chronic lung disease, congestive heart failure, diabetes, hypertension, kidney disease, obesity, osteoporosis, stroke * Scored ≥ 1 point on the FRAIL Scale * Able to give informed consent
Exclusion criteria
* Current or recent (within the past 6 months)participation in progressive resistance training program ≥ 2 times per week * Receiving palliative care * Unable to perform basic activities of daily living or follow 2-step commands (moderate-severe cognitive impairment) * Upcoming travel plans (travelling\> 1 week during the program) * Absolute exercise contraindications (ACSM guidelines)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Through study completion, an average of 12 weeks | The number of participants recruited \>25. |
| Retention | Through study completion, an average of 12 weeks | Feasibility threshold: The number of participants retained at follow-up \>80%. |
| Average Adherence to Nutrition Sessions | Through study completion, an average of 12 weeks | Participants were encouraged to attend 3 nutrition sessions that took place on weeks 2, 4 and 6 of the intervention (12 weeks). Feasibility threshold: Attendance or the average proportion of nutrition sessions \>67% or \>2/3 sessions. |
| Average Adherence to Exercise Sessions | Through study completion, an average of 12 weeks | Participants were encouraged to complete at least 3 exercise sessions per week (one supervised and two independent) for the duration of the intervention (12 weeks). Feasibility threshold: Attendance or the average proportion of exercise sessions completed \>70% or 25.3/36 sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Baseline, week 9, week 12 | Fatigue was assessed using the Center for Epidemiologic Studies Depression Scale-fatigue questions (CES-D) (Radloff, 1977). Only two questions on the CES-D were used: I felt that everything I did was an effort and I could not get going. Scores ranged from of 0-6 and were summed from the two selected questions (lowest response option was Rarely (\<1 day) = 0, highest response option was Nearly every day = 3). Responses closer to the lowest response option indicated a better outcome. |
| Mental Health and Social Isolation | Baseline, week 9, week 12 | The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) was used to assess positive aspects of mental health. Score ranges from 14-70 and were summed from 14 questions (lowest response option was None of the time =1, highest response option was All of the time = 5). Responses closer to the highest response option indicated a better outcome. |
| Physical Activity | Baseline, week 9, week 12 | A Physical Activity Screen (PAS) was used to capture average minutes of moderate-to-vigorous physical activity each week (Clark et al., 2020). This tool was created based on questions used by Exercise is Medicine in the Physical Activity Vital Sign questionnaire (Greenwood et al., 2010). The results were compared to national exercise guidelines for older adults that promote ≥150 minutes and ≥2 session of muscle strengthening per week. A higher score indicated a better outcome. |
| Nutritional Risk | Baseline, week 9, week 12 | The SCREEN tool is a valid and reliable nutrition questionnaire designed specifically for older adults (Keller et al., 2005). This tool was used to assess appetite, understand eating habits, and record recent changes in weight. Scores ranged from of 0-64 and were summed from 14 questions (lowest response option was 0, highest response option was 4). Responses closer to the highest response option indicated a better outcome. |
| Dietary Protein Intake | Baseline, week 9, week 12 | ASA24®-Canada was a guided web-based tool used to record a three 24-hour diet recalls. All food and drinks consumed by the participant on two weekdays and one weekend day (3 days in total) were reported to track protein intake (Subar et al., 2012). An average of the three days was then calculated. |
| Quality of Life Score | Baseline, week 9, week 12 | The EuroQol Group 5 Dimension 5 Level (EQ5D5L) questionnaire was used to evaluate health-related quality of life (Herdman et al., 2011). The system comprised five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had five levels: no problems = 1 to extreme problems = 5. Responses with lower scores indicated a better outcome. An index value ranging from 0-1 is then generated from the equation by from the scores of the five domains (Xie et al. 2016) |
| Exercise Self-efficacy Scale | Baseline, week 9, week 12 | A modified version of the Exercise Self-Efficacy Scale (ESES) was used to assess levels of planning and execution of exercise related activities (Resnick & Jenkins, 2000). There were a total of 11 questions. The lowest response option to each question was Not true at all = 1, while the highest was Exactly true = 5. Responses closer to the highest response option indicate a better outcome. Overall instrument score ranged from 11-55 points. |
| 30-second Chair Stand | Baseline, week 9, week 12 | The 30-second Chair Stand was used to access lower extremity muscle function (Bohannon, 1995; Jones et al., 1999). The instructions for this test were adapted for self-administration under the remote supervisor supervision of the exercise physiologist. A higher score on the test indicated a better outcome. |
| Static Balance | Baseline, week 9, week 12 | Static balance was measured using Short Performance Physical Battery (SPPB) (J. M. Guralnik et al., 1994) balance subscale. The subscale scores ranged from 0-4, with a higher score indicating greater balance. The instructions for this test were adapted for self-administration under the remote supervisor supervision of the exercise physiologist. Please note that the SPPB gait speed and chair stand subscales were not included as a part of the assessment. Therefore the total score for the SPPB (0-12) was not summed. |
Countries
Canada
Participant flow
Recruitment details
Participants were primarily recruited from email or telephone contact lists. In addition, we asked colleagues and collaborators to forward the link to potential participants on their distribution lists. Research support staff and Kinesiologists at two Schlegel Villages and one Luther Villages recruited participants using flyers and word of mouth. The recruitment period went from October 5th, 2020, to December 28th, 2020.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm This was the only arm in the study. All participants were allocated to this arm, where they received an 8-week remotely-delivered exercise and nutrition program.
Exercise program: Participants received two 1-on-1 exercise sessions per week to start. Each session lasted 30 minutes. As progress was made, participants were encouraged to exercise independently outside the structured sessions while continuing to receive a 1-on-1 session each week. The individualized exercises were aligned with functional movements to promote personal relevance: balance, pull, squat, push, hinge, lift & carry and calf raise.
Nutrition education: Participants received a nutrition education booklet and had access to five online videos that correspond to key topics in the booklet (reading nutrition labels, types of protein, foods containing protein, incorporating protein into meals, spreading protein in meals throughout the day). Participants attended three 60-minute nutrition Q&A sessions led by a dietitian, where the group reviewed content from the booklet and videos, and discussed personalized strategies to increase protein intake. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 74 years STANDARD_DEVIATION 7 |
| Race/Ethnicity, Customized Caucasian | 29 Participants |
| Race/Ethnicity, Customized South Asian | 1 Participants |
| Region of Enrollment Canada | 30 Participants |
| Sex/Gender, Customized Female | 26 participants |
| Sex/Gender, Customized Male | 4 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 5 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Average Adherence to Exercise Sessions
Participants were encouraged to complete at least 3 exercise sessions per week (one supervised and two independent) for the duration of the intervention (12 weeks). Feasibility threshold: Attendance or the average proportion of exercise sessions completed \>70% or 25.3/36 sessions.
Time frame: Through study completion, an average of 12 weeks
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Average Adherence to Exercise Sessions | 30.2 sessions | Standard Deviation 6.5 |
Primary
Average Adherence to Nutrition Sessions
Participants were encouraged to attend 3 nutrition sessions that took place on weeks 2, 4 and 6 of the intervention (12 weeks). Feasibility threshold: Attendance or the average proportion of nutrition sessions \>67% or \>2/3 sessions.
Time frame: Through study completion, an average of 12 weeks
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Average Adherence to Nutrition Sessions | 2.5 sessions | Standard Deviation 0.5 |
Primary
Recruitment
The number of participants recruited \>25.
Time frame: Through study completion, an average of 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Recruitment | 30 Participants |
Primary
Retention
Feasibility threshold: The number of participants retained at follow-up \>80%.
Time frame: Through study completion, an average of 12 weeks
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Retention | 28 Participants |
Secondary
30-second Chair Stand
The 30-second Chair Stand was used to access lower extremity muscle function (Bohannon, 1995; Jones et al., 1999). The instructions for this test were adapted for self-administration under the remote supervisor supervision of the exercise physiologist. A higher score on the test indicated a better outcome.
Time frame: Baseline, week 9, week 12
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | 30-second Chair Stand | Baseline | 8.00 number of chair stands completed in 30s | Standard Deviation 2.41 |
| Single Arm | 30-second Chair Stand | End of study | 11.50 number of chair stands completed in 30s | Standard Deviation 2.72 |
| Single Arm | 30-second Chair Stand | Follow-up | 12.54 number of chair stands completed in 30s | Standard Deviation 2.81 |
Secondary
Dietary Protein Intake
ASA24®-Canada was a guided web-based tool used to record a three 24-hour diet recalls. All food and drinks consumed by the participant on two weekdays and one weekend day (3 days in total) were reported to track protein intake (Subar et al., 2012). An average of the three days was then calculated.
Time frame: Baseline, week 9, week 12
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Dietary Protein Intake | Baseline | 79.8 grams of dietary protein | Standard Deviation 9.6 |
| Single Arm | Dietary Protein Intake | End of study | 92.7 grams of dietary protein | Standard Deviation 11.7 |
| Single Arm | Dietary Protein Intake | Follow-up | 89.0 grams of dietary protein | Standard Deviation 11.5 |
Secondary
Exercise Self-efficacy Scale
A modified version of the Exercise Self-Efficacy Scale (ESES) was used to assess levels of planning and execution of exercise related activities (Resnick & Jenkins, 2000). There were a total of 11 questions. The lowest response option to each question was Not true at all = 1, while the highest was Exactly true = 5. Responses closer to the highest response option indicate a better outcome. Overall instrument score ranged from 11-55 points.
Time frame: Baseline, week 9, week 12
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Exercise Self-efficacy Scale | Baseline | 26.4 score on a scale of 11-55 | Standard Deviation 5.2 |
| Single Arm | Exercise Self-efficacy Scale | End of the study | 33.6 score on a scale of 11-55 | Standard Deviation 5.3 |
| Single Arm | Exercise Self-efficacy Scale | Follow-up | 35.0 score on a scale of 11-55 | Standard Deviation 5.6 |
Secondary
Fatigue
Fatigue was assessed using the Center for Epidemiologic Studies Depression Scale-fatigue questions (CES-D) (Radloff, 1977). Only two questions on the CES-D were used: I felt that everything I did was an effort and I could not get going. Scores ranged from of 0-6 and were summed from the two selected questions (lowest response option was Rarely (\<1 day) = 0, highest response option was Nearly every day = 3). Responses closer to the lowest response option indicated a better outcome.
Time frame: Baseline, week 9, week 12
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Fatigue | Baseline | 1.86 score on a scale | Standard Deviation 0.53 |
| Single Arm | Fatigue | End of study | 1.07 score on a scale | Standard Deviation 0.41 |
| Single Arm | Fatigue | Follow-up | 1.14 score on a scale | Standard Deviation 0.46 |
Secondary
Mental Health and Social Isolation
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) was used to assess positive aspects of mental health. Score ranges from 14-70 and were summed from 14 questions (lowest response option was None of the time =1, highest response option was All of the time = 5). Responses closer to the highest response option indicated a better outcome.
Time frame: Baseline, week 9, week 12
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Mental Health and Social Isolation | Baseline | 53.5 score on a scale | Standard Deviation 3.4 |
| Single Arm | Mental Health and Social Isolation | End of study | 54.8 score on a scale | Standard Deviation 3 |
| Single Arm | Mental Health and Social Isolation | Follow-up | 53.5 score on a scale | Standard Deviation 3.5 |
Secondary
Nutritional Risk
The SCREEN tool is a valid and reliable nutrition questionnaire designed specifically for older adults (Keller et al., 2005). This tool was used to assess appetite, understand eating habits, and record recent changes in weight. Scores ranged from of 0-64 and were summed from 14 questions (lowest response option was 0, highest response option was 4). Responses closer to the highest response option indicated a better outcome.
Time frame: Baseline, week 9, week 12
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Nutritional Risk | Baseline | 30.9 score on a scale | Standard Deviation 2.5 |
| Single Arm | Nutritional Risk | End of study | 40.3 score on a scale | Standard Deviation 2.7 |
| Single Arm | Nutritional Risk | Follow-up | 38.8 score on a scale | Standard Deviation 3.3 |
Secondary
Physical Activity
A Physical Activity Screen (PAS) was used to capture average minutes of moderate-to-vigorous physical activity each week (Clark et al., 2020). This tool was created based on questions used by Exercise is Medicine in the Physical Activity Vital Sign questionnaire (Greenwood et al., 2010). The results were compared to national exercise guidelines for older adults that promote ≥150 minutes and ≥2 session of muscle strengthening per week. A higher score indicated a better outcome.
Time frame: Baseline, week 9, week 12
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Physical Activity | Baseline | 180 weekly minutes of physical activity | Standard Deviation 82 |
| Single Arm | Physical Activity | End of the study | 310 weekly minutes of physical activity | Standard Deviation 85 |
| Single Arm | Physical Activity | Follow-up | 263 weekly minutes of physical activity | Standard Deviation 71 |
Secondary
Quality of Life Score
The EuroQol Group 5 Dimension 5 Level (EQ5D5L) questionnaire was used to evaluate health-related quality of life (Herdman et al., 2011). The system comprised five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had five levels: no problems = 1 to extreme problems = 5. Responses with lower scores indicated a better outcome. An index value ranging from 0-1 is then generated from the equation by from the scores of the five domains (Xie et al. 2016)
Time frame: Baseline, week 9, week 12
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Quality of Life Score | Baseline | 0.832 index value/scores on a scale | Standard Deviation 0.024 |
| Single Arm | Quality of Life Score | End of study | 0.805 index value/scores on a scale | Standard Deviation 0.034 |
| Single Arm | Quality of Life Score | Follow-up | 0.807 index value/scores on a scale | Standard Deviation 0.038 |
Secondary
Static Balance
Static balance was measured using Short Performance Physical Battery (SPPB) (J. M. Guralnik et al., 1994) balance subscale. The subscale scores ranged from 0-4, with a higher score indicating greater balance. The instructions for this test were adapted for self-administration under the remote supervisor supervision of the exercise physiologist. Please note that the SPPB gait speed and chair stand subscales were not included as a part of the assessment. Therefore the total score for the SPPB (0-12) was not summed.
Time frame: Baseline, week 9, week 12
Population: 2 participants withdrew from the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Static Balance | Baseline | 3.54 score on a scale | Standard Deviation 0.39 |
| Single Arm | Static Balance | End of study | 3.64 score on a scale | Standard Deviation 0.39 |
| Single Arm | Static Balance | Follow-up | 3.82 score on a scale | Standard Deviation 0.26 |