Physical Inactivity
Conditions
Keywords
physical activity, physical function
Brief summary
This pilot study will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely (via Zoom) to increase physical function and activity among residents of a HUD subsidized independent-living senior housing community. The intervention is called Tele-Video to Improve Daily Activity (T-VIDA) and will be administered with two cohorts of residents in a single community. The study has two main goals: 1) To determine if an OT-led program administered remotely over the internet using Zoom is useful in helping residents increase their physical activity; and 2) to determine if involving respected members of the community in the program as Advisory Committee members has an impact on how much other residents participate in program activities and engage in behaviors discussed. The OT intervention will be comprised of a combination of adapted components from multiple evidence-based interventions including individual meetings with an OT and OT-led group sessions. To evaluate the intervention pre- and post-program interviews will be conducted with participants over the phone, and activity monitoring will be conducted after both the pre- and post-program interviews for 7-days using an activity monitoring device. The following hypotheses will be tested: 1) at least 75% (3 of 4) of identified residents will accept the invitation to serve on the Advisory Committee; 2) Advisory Committee Members will attend at least 2 of 3 committee meetings; 3) Participants will on average participate in at least 70% (7 of 10) of intervention activities; 4) Residents knowing one or more committee members at baseline will participate in more intervention activities compared to those who do not; and 5) The influence of knowing a committee member on participation will be greater among residents reporting more pain at baseline compared to those reporting less pain.
Interventions
Participants will be asked to meet individually with an Occupational Therapist (OT) via Zoom to assess activity performance, establish short-term activity goals, and outline an individualized home exercise program. Participants will also be asked to participate in 4 weekly one hour group sessions via Zoom that will include: 1) education; 2) OT facilitated discussion; and 3) activity demonstration, engagement and feedback. The following topics will be covered: mobility, physical activity, pain management, and energy conservation. Participants will be asked to meet individually with the OT via Zoom for 15-20 minutes weekly to answer questions. At the end, participants will be asked to again meet individually with the OT via Zoom to re-assess activity performance and revisit short-term activity goals and the individualized home exercise program. Advisory Committee Members will be asked to make note of intervention activities during their regular interactions with other participants.
Sponsors
Study design
Eligibility
Inclusion criteria
* resident of the senior housing community of focus * English-proficient * ambulatory with or without assistive device (e.g., cane, walker)
Exclusion criteria
* requiring use of a wheelchair for ambulation; * requiring highly specialized equipment (e.g., spinal cord injury, leg amputation, wound vacuum assisted closure, heavy leg boot); * hospitalized within last 3 months; * has probable dementia (TICSm score \<27); * requiring ongoing complicated treatments (e.g., home oxygen use \>2 liters); * has active mental health condition judged to pose significant barrier to participation; and * meets CDC recommendations for physical activity (150+ minutes of moderate-intensity aerobic activity during typical week).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Process Outcome - Advisory Committee Members Accept Invitation | 1 week pre-intervention | Number of originally identified potential Advisory Commitee Members who accept the invitation to serve on the committee. Possible scores range from 0 to 1. |
| Process Outcome - Advisory Committee Member Participation | Week 5 of intervention | Number of committee meetings attended by Advisory Committee Members. Possible scores range from 0 to 3. |
| Process Outcome - Individual Activity Participation | Immediately after the intervention, 6 weeks after the intervention started | Number of individual (one-on-one) intervention activities attended by participants. Possible scores range from 0 to 6. |
| Process Outcome - Group Activity Participation | Immediately after the intervention, 6 weeks after the intervention started | Number of group intervention activities attended by participants. Possible scores range from 0 to 4. |
| Process Outcome - Total Activity Participation | Immediately after the intervention, 6 weeks after the intervention started | Total number of intervention activities attended by participants (individual and group). Possible scores range from 0 to 10. |
| Process Outcome - Number Acitivites Via Zoom | Immediately after the intervention, 6 weeks after the intervention started | Number of activities attended via zoom as opposed to calling in by telephone. Possible scores range from 0 to 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference | 1 week pre and 1 week post the 6-week intervention | This includes 8 questions/items that measure how much pain interferes with daily activities. The response scale for each the 8 items ranges from 1=not at all to 5=very much. On this scale, lower values represent a better outcome. A total pain interference score is calculated by averaging the score of all 8 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in pain interference. |
| Change in Pain Intensity | 1 week pre and 1 week post the 6-week intervention | This includes one question about how participants rate their pain on average using a scale ranging from 0=no pain to 10=the worst imaginable pain. Change will be measured by creating a difference score between the pre and post intervention scores. |
| Change in Physical Function Difficulty | 1 week pre and 1 week post the 6-week intervention | This includes a modified version of the National Health and Aging Trends Study disability and functioning measure. The measure includes 11 questions/items assessing difficulty performing self-care, mobility, and household activities. The response scale for each of the 11 items asking about difficulty doing these activities ranges from 1=none to 4=a lot. On this scale, lower values represent a better outcome. A total physical function difficulty score is calculated by averaging the score of all 11 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in physical function difficulty. |
| Change in Self-efficacy in Activity | 1 week pre and 1 week post the 6-week intervention | This includes 10 questions/items that measure participants' confidence in doing a number of activities that will be discussed during the intervention. The response scale for each of the 10 items ranges from 1=not confident at all to 5=completely confident. On this scale, higher values represent a better outcome. A total self-efficacy in activity score is calculated by averaging the score of all 10 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Positive change scores represent a better outcome, i.e., an increase in self-efficacy in activity. |
| Change in Percentage of Other Participants Known | 1 week pre and 1 week post the 6-week intervention | This will include a measure of the percentage of other participants each participant reports knowing. Possible scores range from 0 to 100. Change will be measured by creating a difference score between the pre and post intervention scores. |
| Change in Respect Level of Other Participants | 1 week pre and 1 week post the 6-week intervention | This will include a measure of how much respect on average participants have for the other participants that they report knowing. This question will be asked on a scale ranging from 1=respect them very much to 5=don't respect them at all. Change will be measured by creating a difference score between the pre and post intervention scores. |
| Change in Sedentary Behavior | 1 week pre and 1 week post the 6-week intervention | Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average amount of time that participants were sedentary per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores. |
| Change in Number of Steps | 1 week pre and 1 week post the 6-week intervention | Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average number of steps taken per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores. |
| Change in Self-reported Physical Activity | 1 week pre and 1 week post the 6-week intervention | We use two items from the Community Health Activities Model Program questionnaire asking if participants in a typical week in the past month: 1) walked fast or briskly for exercise; and 2) did light strength training, i.e., used hand held weights of 5 lbs. or less or elastic bands. The response scale for each of the two items was 0=no or 1=yes. A self-reported physical activity score for is calculated for each participant by summing the number of items participants indicated doing, i.e., indicated yes. The range for the total score ranges from 0 to 2. Change will be measured by creating a difference score between the pre and post intervention self-reported physical activity score. Positive change scores represent a better outcome, i.e., an increase in self-reported physical activity. |
| Change in Perceived Barriers to Physical Activity | 1 week pre and 1 week post the 6-week intervention | This includes 16 questions/items that measure the degree to which specific things make it more difficult for participants to engage in 30 minutes of moderate intensity physical activity on 5 or more days a week. The response scale for each of the 16 items ranges from 1=not at all more difficult to 4=much more difficult. On this scale, lower values represent a better outcome. A total perceived barriers to physical activity score is calculated by averaging the score of all 16 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in perceived barriers to physical activity. |
Countries
United States
Contacts
University of Michigan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Occupational Therapy Intervention Group Behavioral: Tele-Video to Improve Daily Activity Participants will be asked to meet individually with an Occupational Therapist (OT) via Zoom to assess activity performance, establish short-term activity goals, and outline an individualized home exercise program. Participants will also be asked to participate in 4 weekly one hour group sessions via Zoom that will include: 1) education; 2) OT facilitated discussion; and 3) activity demonstration, engagement and feedback. The following topics will be covered: mobility, physical activity, pain management, and energy conservation. Participants will be asked to meet individually with the OT via Zoom for 15-20 minutes weekly to answer questions. At the end, participants will be asked to again meet individually with the OT via Zoom to re-assess activity performance and revisit short-term activity goals and the individualized home exercise program. Advisory Committee Members will be asked to make note of intervention activities during their regular interactions with other participants. Advisory Committee Members will be selected from the group of enrolled participants, and will not be considered additional participants in the study. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Experimental: Occupational Therapy Intervention Group |
|---|---|
| Age, Continuous | 78 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 4 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Process Outcome - Advisory Committee Member Participation
Number of committee meetings attended by Advisory Committee Members. Possible scores range from 0 to 3.
Time frame: Week 5 of intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: occupational therapy intervention group | Process Outcome - Advisory Committee Member Participation | 3 Number of meetings attended |
Process Outcome - Advisory Committee Members Accept Invitation
Number of originally identified potential Advisory Commitee Members who accept the invitation to serve on the committee. Possible scores range from 0 to 1.
Time frame: 1 week pre-intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: occupational therapy intervention group | Process Outcome - Advisory Committee Members Accept Invitation | 1 Participants |
Process Outcome - Group Activity Participation
Number of group intervention activities attended by participants. Possible scores range from 0 to 4.
Time frame: Immediately after the intervention, 6 weeks after the intervention started
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Process Outcome - Group Activity Participation | 3.5 Number of group activities attended | Standard Deviation 0.71 |
Process Outcome - Individual Activity Participation
Number of individual (one-on-one) intervention activities attended by participants. Possible scores range from 0 to 6.
Time frame: Immediately after the intervention, 6 weeks after the intervention started
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Process Outcome - Individual Activity Participation | 5.8 Number of one-on-one activities attended | Standard Deviation 0.4 |
Process Outcome - Number Acitivites Via Zoom
Number of activities attended via zoom as opposed to calling in by telephone. Possible scores range from 0 to 10.
Time frame: Immediately after the intervention, 6 weeks after the intervention started
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Process Outcome - Number Acitivites Via Zoom | 9.38 Number of activities attended on Zoom | Standard Deviation 0.99 |
Process Outcome - Total Activity Participation
Total number of intervention activities attended by participants (individual and group). Possible scores range from 0 to 10.
Time frame: Immediately after the intervention, 6 weeks after the intervention started
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Process Outcome - Total Activity Participation | 9.38 # of intervention activities attended | Standard Deviation 0.99 |
Change in Number of Steps
Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average number of steps taken per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Number of Steps | -85.5 Accelerometer step count per day | Standard Deviation 834.52 |
Change in Pain Intensity
This includes one question about how participants rate their pain on average using a scale ranging from 0=no pain to 10=the worst imaginable pain. Change will be measured by creating a difference score between the pre and post intervention scores.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Pain Intensity | -1.20 Units on a scale | Standard Deviation 1.79 |
Change in Pain Interference
This includes 8 questions/items that measure how much pain interferes with daily activities. The response scale for each the 8 items ranges from 1=not at all to 5=very much. On this scale, lower values represent a better outcome. A total pain interference score is calculated by averaging the score of all 8 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in pain interference.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Pain Interference | -0.43 Units on a scale | Standard Deviation 0.46 |
Change in Perceived Barriers to Physical Activity
This includes 17 questions/items that measure the degree to which specific things make it more difficult for participants to engage in 30 minutes of moderate intensity physical activity on 5 or more days a week. The response scale for each of the 17 items ranges from 1=not at all more difficult to 4=much more difficult. On this scale, lower values represent a better outcome. A total perceived barriers to physical activity score is calculated by averaging the score of all 17 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in perceived barriers to physical activity.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Perceived Barriers to Physical Activity | -0.05 Units on a scale | Standard Deviation 0.16 |
Change in Percentage of Other Participants Known
This will include a measure of the percentage of other participants each participant reports knowing. Possible scores range from 0 to 100. Change will be measured by creating a difference score between the pre and post intervention scores.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Percentage of Other Participants Known | 50 Percentage of other participants known | Standard Deviation 35 |
Change in Physical Function Difficulty
This includes a modified version of the National Health and Aging Trends Study disability and functioning measure. The measure includes 11 questions/items assessing difficulty performing self-care, mobility, and household activities. The response scale for each of the 11 items asking about difficulty doing these activities ranges from 1=none to 4=a lot. On this scale, lower values represent a better outcome. A total physical function difficulty score is calculated by averaging the score of all 11 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in physical function difficulty.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Physical Function Difficulty | 0.25 Units on a scale | Standard Deviation 0.4 |
Change in Respect Level of Other Participants
This will include a measure of how much respect on average participants have for the other participants that they report knowing. This question will be asked on a scale ranging from 1=respect them very much to 5=don't respect them at all. Change will be measured by creating a difference score between the pre and post intervention scores.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Respect Level of Other Participants | 0.37 Units on a scale | Standard Deviation 0.28 |
Change in Sedentary Behavior
Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average amount of time that participants were sedentary per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Sedentary Behavior | 46.45 Minutes per day | Standard Deviation 116.36 |
Change in Self-efficacy in Activity
This includes 10 questions/items that measure participants' confidence in doing a number of activities that will be discussed during the intervention. The response scale for each of the 10 items ranges from 1=not confident at all to 5=completely confident. On this scale, higher values represent a better outcome. A total self-efficacy in activity score is calculated by averaging the score of all 10 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Positive change scores represent a better outcome, i.e., an increase in self-efficacy in activity.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Self-efficacy in Activity | -0.10 Units on a scale | Standard Deviation 0.51 |
Change in Self-reported Physical Activity
Modified Community Health Activities Model Program questionnaire. This includes 16 questions/items that measure the number of times and the frequency of each activity engaged in during a typical week in the past month. The response scale for each of the 16 items ranges from 1=less than 1 hour to 6=9 or more hours. On this scale, higher values represent a better outcome. A total self-reported physical activity score is calculated by averaging the score of all 16 items. The range for the total score also ranges from 1 to 6. Change will be measured by creating a difference score between the pre and post intervention total scores. Positive change scores represent a better outcome, i.e., an increase in self-reported physical activity.
Time frame: 1 week pre and 1 week post the 6-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: occupational therapy intervention group | Change in Self-reported Physical Activity | 0.20 Units on scale | Standard Deviation 0.45 |