| Primary | Adherence to the Multicomponent Telehealth Intervention | Adherence will be calculated as the proportion of the number of sessions attended out of the number prescribed per protocol (32 sessions) | All participants; data from both groups will be pooled for analysis. | Posted | | Median | Inter-Quartile Range | Proportion of sessions attended | | Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2) | Sessions | Sessions | | ID | Title | Description |
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| OG000 | All Participants | |
| | Units | Counts |
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| Participants | | | Sessions | |
| | Title | Denominators | Categories |
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| Secondary | Physical Activity | Physical activity will be measured via accelerometry and will include average 7-day step count | All participants with complete step count data will be analyzed. Since only pre-program and post-program data were collected, the data were pooled to increase statistical power. | Posted | | Median | Inter-Quartile Range | steps | | Change from pre-program (baseline for Group 1, 12 weeks for Group 2) to post-program (12 weeks for Group 1, 24 weeks for Group 2). | | | | ID | Title | Description |
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| OG000 | All Participants | |
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| Secondary | Feasibility of the Multicomponent Telehealth Intervention | Feasibility will be measured through a validated survey: Feasibility of Intervention Measure consists of 4 items rated on a 5-point Likert scale (1) completely disagree to (5) completely agree. The average of the 4 items are reported. Higher scores indicate greater feasibility of the program. | All participants with complete data; data from both groups will be pooled for analysis. | Posted | | Median | Inter-Quartile Range | units on a scale | | Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2) | | | | ID | Title | Description |
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| OG000 | All Participants | |
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| Secondary | Acceptability of the Multicomponent Telehealth Intervention | Acceptability will be measured through a validated survey: Acceptability of Intervention Measure consists of 4 items rated on a 5-point Likert scale (1) completely disagree to (5) completely agree. The average of the 4 items are reported. Higher scores indicate greater acceptability of the program." | All participants with complete data; data from both groups will be pooled for analysis. | Posted | | Median | Inter-Quartile Range | score on a scale | | Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2) | | | | ID | Title | Description |
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| OG000 | All Participants | |
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| Secondary | Participant Recruitment | Recruitment will be tracked as part of feasibility and to inform a future trial. Recruitment will be reported as a proportion of those enrolled out of the total number screened via phone screen. | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
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| OG000 | Recruitment | Proportion of number enrolled from number completing phone screen. |
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| Secondary | Satisfaction of the Multicomponent Telehealth Intervention | Participation satisfaction with care provided via telerehabilitation will be assessed via the VA's approved survey: V-signals. It consists of 11 items rated on a 5-point Likert scale from (1) strongly disagree to (5) strongly agree). The average of the 11 items are reported. Higher scores indicate better satisfaction. | All participants with complete data; data from both groups will be pooled for analysis. | Posted | | Median | Inter-Quartile Range | score on a scale | | Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2) | | | | ID | Title | Description |
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| OG000 | All Participants | |
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| Secondary | Safety Event Count | The Safety Event Count is the cumulative number of study related (possibly, probably, or definitely) adverse events and severe adverse events counted from baseline to program end. Events will be categorized by type | | Posted | | Number | | number of adverse events | | Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2) | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group1) | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise | | OG001 | Education (Group2) | This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene |
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| Secondary | Exercise Stages of Change Questionnaire | Four-item questionnaire used to determine an individual's stage of change (pre-contemplation, contemplation, preparation, action, or maintenance) | | Posted | | Count of Participants | | Participants | No | Change from Baseline to 12 weeks | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group1) Baseline | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise | | OG001 | Multicomponent Telehealth Intervention (Group 1) 12 Weeks | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise |
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| Secondary | Self-efficacy for Exercise (SEE) Scale | Nine item questionnaire used to measure an individual's self-efficacy for exercising under different conditions. Each item is rated on a scale of 0 (not confident) to 10 (confident). The average of the 9 items is calculated; higher scores indicate better self-efficacy. The change from baseline to 12 weeks is calculated as 12 weeks minus baseline; thus, positive change scores indicate improvement in self-efficacy. | All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis. | Posted | | Median | Inter-Quartile Range | score on a scale | | Change from Baseline to 12 weeks | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group1) | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise | |
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| Secondary | 30 Second Sit to Stand | The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function. | All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis. | Posted | | Median | Inter-Quartile Range | Number of sit to stand repetitions | | Change from Baseline to 12 weeks | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group1) | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise | | OG001 | Education (Group2) | This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene |
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| Secondary | Arm Curl Test | This is a functional performance test for upper body strength and is performed on each arm (one arm at a time). It requires the participant to perform as many arm curls (biceps curls) as possible in 30 seconds. Males use an 8lb weight and females use a 5lb weight. Scores are continuous, and higher scores indicate greater arm strength (better outcome) | All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis. Group 2 had 1 participant not complete this outcome measure. | Posted | | Median | Inter-Quartile Range | Number of arm curl repetitions | | Change from Baseline to 12 weeks | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group1) | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise | |
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| Secondary | 2-minute Step Test | This is a functional performance test for aerobic endurance. It requires participants to march in place for 2 minutes (alternating legs), and the score is the number of repetitions completed on the right leg. Scores are continuous, and higher scores indicate better aerobic endurance. | All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis. | Posted | | Median | Inter-Quartile Range | number of repetitions | | Change from Baseline to 12 weeks | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group1) | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise | | OG001 | Education (Group2) | |
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| Secondary | Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form | This questionnaire consists of 18 items rated on a 4-point Likert scale from 1 (unable) to 4 (none) to address the prompt: How much difficulty do you currently have. The total score is reported by summing each item; scores can range from 18 to 72. Higher scores indicate better mobility and less impairment/disability. | All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis. | Posted | | Median | Inter-Quartile Range | units on a scale | | Change from Baseline to 12 weeks | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group1) | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise | | OG001 |
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| Secondary | 3-Item Loneliness Scale | This scale has three items and a simplified set of response categories that is designed to measure overall loneliness. Score range: 3-9. Higher scores indicate higher loneliness. | All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis. | Posted | | Median | Inter-Quartile Range | units on a scale | | Change from Baseline to 12 weeks | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group1) | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise | | OG001 | Education (Group2) | This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene |
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| Secondary | PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only | This is a patient reported outcome measure to assess physical health (subscale) and mental health (subscale). It is a 29-item questionnaire, and most items are rated on a 5-point Likert scale. There is 1 pain intensity item rated on a 0 (no pain) to 10 (worst pain imaginable) scale. PROMIS scores were transformed to a T-score where 50 represents the population mean, and the standard deviation is 10. The method reported by Hays et al. in 2018 was used to calculate the physical health and mental health subscales. Higher scores for subscales listed indicate better physical and mental health. | All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis. | Posted | | Median | Inter-Quartile Range | score on a scale | | Change from Baseline to 12 weeks | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group1) | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise |
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| Secondary | Participant Retention | Participant retention will be tracked as part of feasibility and to inform a future trial. Retention will be reported as a proportion of the total number of participants who complete all outcome measure timepoints out of the total who complete baseline measures. | Total number of participants. The investigators considered retention to be study retention in addition to intervention retention, which included the outcome assessments at all time points. Thus, even though participants in Group 1 did not receive any intervention from weeks 12-24, they were still considered enrolled in the study until their 24 week outcome assessment was completed, they withdrew, or were lost to follow-up. | Posted | | Count of Participants | | Participants | | 12 Weeks and 24 Weeks | | | | ID | Title | Description |
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| OG000 | Multicomponent Telehealth Intervention (Group 1) | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise |
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