Trial Outcomes & Findings for Examining a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis (NCT NCT05888727)
NCT ID: NCT05888727
Last Updated: 2026-01-30
Results Overview
Feasibility of the intervention will be measured based on reaching recruitment goals (n=24) within a one-year period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
16-weeks
Results posted on
2026-01-30
Participant Flow
Of the 24 participants enrolled, only 23 were randomized.
Participant milestones
| Measure |
Exercise Training Intervention
Seated Physical activity INtervention for persons with MS, "SPIN" program- Intervention Condition: The proposed exercise training program is based on Social Cognitive Theory (SCT) for promoting aerobic and strength training in wheelchair users with MS. The 16-week program includes one-on-one video chats with a behavioral coach and various "tracks" for progressive increases in both strength and aerobic training. The proposed strength training includes 15 exercises with step-by-step instructions using resistance bands and/or wrist weights that were adapted for seated body-position that can be executed in a wheelchair. The proposed aerobic training is arm cycle ergometry; this is a low-cost and modifiable option that fits the needs of both power and manual wheelchair users. Other proposed equipment includes a comprehensive Training Manual, fitness tracker for use during exercise training sessions, and Rate of Perceived Exertion (RPE) scale for guiding individualized exercise intensity. The research team created 12 Newsletters that align with 12 proposed coaching calls.
|
Wellness Control
WEllness for Longevity Living with MS (WELL)- Control Condition: The attention/contact wellness control condition will mirror the exercise training intervention condition, but focuses on implementing health behaviors other than physical activity (e.g., diet and emotional wellbeing). This program is an adapted version of the WellMS program from Prof. Motl's Phase III clinical trial (NCT03490240). The program is based on SCT principles of behavior change and integrates wellness resources from the National MS Society (NMSS). The research team has created 12 Newsletters that will be delivered on the same chat schedule as the exercise training intervention. All coaching chats and newsletters will occur with the same frequency as in the exercise training intervention condition. Participants will be provided with a participant manual, logbook, and calendar. Participants will work with their behavioral coach on goal setting specific to wellness behaviors.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Exercise Training Intervention
n=12 Participants
Seated Physical activity INtervention for persons with MS, "SPIN" program- Intervention Condition: The proposed exercise training program is based on Social Cognitive Theory (SCT) for promoting aerobic and strength training in wheelchair users with MS. The 16-week program includes one-on-one video chats with a behavioral coach and various "tracks" for progressive increases in both strength and aerobic training. The proposed strength training includes 15 exercises with step-by-step instructions using resistance bands and/or wrist weights that were adapted for seated body-position that can be executed in a wheelchair. The proposed aerobic training is arm cycle ergometry; this is a low-cost and modifiable option that fits the needs of both power and manual wheelchair users. Other proposed equipment includes a comprehensive Training Manual, fitness tracker for use during exercise training sessions, and Rate of Perceived Exertion (RPE) scale for guiding individualized exercise intensity. The research team created 12 Newsletters that align with 12 proposed coaching calls.
|
Wellness Control
n=11 Participants
WEllness for Longevity Living with MS (WELL)- Control Condition: The attention/contact wellness control condition will mirror the exercise training intervention condition, but focuses on implementing health behaviors other than physical activity (e.g., diet and emotional wellbeing). This program is an adapted version of the WellMS program from Prof. Motl's Phase III clinical trial (NCT03490240). The program is based on SCT principles of behavior change and integrates wellness resources from the National MS Society (NMSS). The research team has created 12 Newsletters that will be delivered on the same chat schedule as the exercise training intervention. All coaching chats and newsletters will occur with the same frequency as in the exercise training intervention condition. Participants will be provided with a participant manual, logbook, and calendar. Participants will work with their behavioral coach on goal setting specific to wellness behaviors.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.58 years
STANDARD_DEVIATION 12.94 • n=41 Participants
|
61.18 years
STANDARD_DEVIATION 14.72 • n=1581 Participants
|
56.17 years
STANDARD_DEVIATION 14.36 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Latino/a
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=41 Participants
|
11 participants
n=1581 Participants
|
23 participants
n=4626 Participants
|
|
Disease Duration
|
10.91 years
STANDARD_DEVIATION 8.98 • n=41 Participants
|
22.30 years
STANDARD_DEVIATION 12.05 • n=1581 Participants
|
15.7 years
STANDARD_DEVIATION 11.9 • n=4626 Participants
|
|
Patient Determined Disease Steps
|
7 score on a scale
n=41 Participants
|
7 score on a scale
n=1581 Participants
|
7 score on a scale
n=4626 Participants
|
|
Type of MS
Relapsing Remitting Multiple Sclerosis (RRMS)
|
3 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Type of MS
Secondary Progressive Multiple Sclerosis (SPMS)
|
1 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Type of MS
Primary Progressive Multiple Sclerosis (PPMS)
|
8 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
11 Participants
n=4626 Participants
|
|
Wheelchair type
Power wheelchair
|
5 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
11 Participants
n=4626 Participants
|
|
Wheelchair type
Manual wheelchair
|
5 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Wheelchair type
Power scooter
|
2 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Education
Less than College
|
2 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Education
1-3 Years of College
|
4 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
7 Participants
n=4626 Participants
|
|
Education
College Graduate or More
|
6 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
|
Household Income
$50,000 or Less
|
6 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
11 Participants
n=4626 Participants
|
|
Household Income
$50,001 or Greater
|
6 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
10 Participants
n=4626 Participants
|
|
Household Income
Prefer to not respond
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Marital Status
Married
|
5 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
11 Participants
n=4626 Participants
|
|
Marital Status
Single/Divorced/Separated/Widowed
|
7 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Employed
Yes
|
2 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Employed
No
|
10 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
19 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: 16-weeksFeasibility of the intervention will be measured based on reaching recruitment goals (n=24) within a one-year period.
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Wellness Control
WEllness for Longevity Living with MS (WELL)- Control Condition: The attention/contact wellness control condition will mirror the exercise training intervention condition, but focuses on implementing health behaviors other than physical activity (e.g., diet and emotional wellbeing). This program is an adapted version of the WellMS program from Prof. Motl's Phase III clinical trial (NCT03490240). The program is based on SCT principles of behavior change and integrates wellness resources from the National MS Society (NMSS). The research team has created 12 Newsletters that will be delivered on the same chat schedule as the exercise training intervention. All coaching chats and newsletters will occur with the same frequency as in the exercise training intervention condition. Participants will be provided with a participant manual, logbook, and calendar. Participants will work with their behavioral coach on goal setting specific to wellness behaviors.
|
|---|---|---|
|
Study Feasibility: Number of Participants Recruited
|
24 Participants
|
—
|
PRIMARY outcome
Timeframe: 16-weeksFeasibility of the intervention will be measured based on retention of \>80% of enrolled participants for the full 16-week study period.
Outcome measures
| Measure |
All Eligible Participants
n=12 Participants
All eligible participants
|
Wellness Control
n=11 Participants
WEllness for Longevity Living with MS (WELL)- Control Condition: The attention/contact wellness control condition will mirror the exercise training intervention condition, but focuses on implementing health behaviors other than physical activity (e.g., diet and emotional wellbeing). This program is an adapted version of the WellMS program from Prof. Motl's Phase III clinical trial (NCT03490240). The program is based on SCT principles of behavior change and integrates wellness resources from the National MS Society (NMSS). The research team has created 12 Newsletters that will be delivered on the same chat schedule as the exercise training intervention. All coaching chats and newsletters will occur with the same frequency as in the exercise training intervention condition. Participants will be provided with a participant manual, logbook, and calendar. Participants will work with their behavioral coach on goal setting specific to wellness behaviors.
|
|---|---|---|
|
Study Feasibility: Number of Participants Retained
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 16-weeksOutcome measures
| Measure |
All Eligible Participants
n=12 Participants
All eligible participants
|
Wellness Control
n=11 Participants
WEllness for Longevity Living with MS (WELL)- Control Condition: The attention/contact wellness control condition will mirror the exercise training intervention condition, but focuses on implementing health behaviors other than physical activity (e.g., diet and emotional wellbeing). This program is an adapted version of the WellMS program from Prof. Motl's Phase III clinical trial (NCT03490240). The program is based on SCT principles of behavior change and integrates wellness resources from the National MS Society (NMSS). The research team has created 12 Newsletters that will be delivered on the same chat schedule as the exercise training intervention. All coaching chats and newsletters will occur with the same frequency as in the exercise training intervention condition. Participants will be provided with a participant manual, logbook, and calendar. Participants will work with their behavioral coach on goal setting specific to wellness behaviors.
|
|---|---|---|
|
Study Feasibility: Number of Participants With Study-Related Adverse Events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16-weeksPopulation: Data were only collected from participants who completed a semi-structured interview.
Acceptability was assessed through semi-structured interviews conducted with participants. Positive perception was defined as participants expressing favorable views or satisfaction with the intervention. Reported is the number of participants who expressed positive perceptions during the interview.
Outcome measures
| Measure |
All Eligible Participants
n=9 Participants
All eligible participants
|
Wellness Control
n=8 Participants
WEllness for Longevity Living with MS (WELL)- Control Condition: The attention/contact wellness control condition will mirror the exercise training intervention condition, but focuses on implementing health behaviors other than physical activity (e.g., diet and emotional wellbeing). This program is an adapted version of the WellMS program from Prof. Motl's Phase III clinical trial (NCT03490240). The program is based on SCT principles of behavior change and integrates wellness resources from the National MS Society (NMSS). The research team has created 12 Newsletters that will be delivered on the same chat schedule as the exercise training intervention. All coaching chats and newsletters will occur with the same frequency as in the exercise training intervention condition. Participants will be provided with a participant manual, logbook, and calendar. Participants will work with their behavioral coach on goal setting specific to wellness behaviors.
|
|---|---|---|
|
Acceptability: Number of Participants With Positive Perceptions During Semi-Structured Interview
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 16-weeksPopulation: Data was only collected from participants who completed the survey
The post-intervention acceptability Survey total score ranges from 1 to 5, a higher score indicates greater acceptability.
Outcome measures
| Measure |
All Eligible Participants
n=10 Participants
All eligible participants
|
Wellness Control
n=9 Participants
WEllness for Longevity Living with MS (WELL)- Control Condition: The attention/contact wellness control condition will mirror the exercise training intervention condition, but focuses on implementing health behaviors other than physical activity (e.g., diet and emotional wellbeing). This program is an adapted version of the WellMS program from Prof. Motl's Phase III clinical trial (NCT03490240). The program is based on SCT principles of behavior change and integrates wellness resources from the National MS Society (NMSS). The research team has created 12 Newsletters that will be delivered on the same chat schedule as the exercise training intervention. All coaching chats and newsletters will occur with the same frequency as in the exercise training intervention condition. Participants will be provided with a participant manual, logbook, and calendar. Participants will work with their behavioral coach on goal setting specific to wellness behaviors.
|
|---|---|---|
|
Acceptability as Measured by the Post-intervention Acceptability Survey
|
4.5 score on a scale
Standard Deviation 0.97
|
4.56 score on a scale
Standard Deviation 0.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksPhysical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Total Godin Leisure Time Exercise Questionnaire scores range from 0-119, with higher scores indicating more exercise behavior. Participants will complete this questionnaire at baseline and 16 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksTriglycerides will be measured in partnership with Quest Diagnostics using the standard Diabetes Risk without Score panel at a location convenient to participants within their community. Participants will complete blood sample collection at baseline and 16 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksHbA1c will be measured in partnership with Quest Diagnostics using the standard Diabetes Risk without Score panel at a location convenient to participants within their community. Participants will complete blood sample collection at baseline and 16 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksCholesterol levels will be measured in partnership with Quest Diagnostics using the standard Diabetes Risk without Score panel at a location convenient to participants within their community. Participants will complete blood sample collection at baseline and 16 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksFasting glucose will be measured in partnership with Quest Diagnostics using the standard Diabetes Risk without Score panel at a location convenient to participants within their community. Participants will complete blood sample collection at baseline and 16 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksWe will ask all participants to complete a weekly form in an individual REDCap portal with the information from their logbook as an additional measure of adherence to the exercise training or wellness program (i.e., behavior change).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksFatigue will be assessed using the Fatigue Severity Scale. Fatigue Severity Scale scores range from 9-63, with higher scores indicating greater fatigue. Participants will complete this questionnaire at baseline and 16 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksPain will be assessed using the McGill Pain Questionnaire-Short Form. McGill Pain Questionnaire-Short Form scores range from 0-45, with higher scores indicating greater pain. Participants will complete this questionnaire at baseline and 16 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksDepressive symptoms will be assessed using the Hospital Anxiety and Depression Scale. Hospital Anxiety and Depression Scale depression subscale scores range from 0-21, with higher scores indicating greater depressive symptoms. Participants will complete this questionnaire at baseline and 16 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksQuality of life will be assessed using the 12-item Short Form Survey. The 12-item Short Form Survey scores include mental and physical component subscale scores, which each range from 0-100, with higher scores indicating greater quality of life. Participants will complete this questionnaire at baseline and 16 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16-weeksPhysical activity will be assessed using an ActiGraph accelerometer. Participants will wear an accelerometer on a wristband on their nondominant wrist during the waking hours of a 7 day period. Participants will complete this at baseline and 16 weeks.
Outcome measures
Outcome data not reported
Adverse Events
Exercise Training Intervention
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Wellness Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exercise Training Intervention
n=12 participants at risk
Seated Physical activity INtervention for persons with MS, "SPIN" program- Intervention Condition: The proposed exercise training program is based on Social Cognitive Theory (SCT) for promoting aerobic and strength training in wheelchair users with MS. The 16-week program includes one-on-one video chats with a behavioral coach and various "tracks" for progressive increases in both strength and aerobic training. The proposed strength training includes 15 exercises with step-by-step instructions using resistance bands and/or wrist weights that were adapted for seated body-position that can be executed in a wheelchair. The proposed aerobic training is arm cycle ergometry; this is a low-cost and modifiable option that fits the needs of both power and manual wheelchair users. Other proposed equipment includes a comprehensive Training Manual, fitness tracker for use during exercise training sessions, and Rate of Perceived Exertion (RPE) scale for guiding individualized exercise intensity. The research team created 12 Newsletters that align with 12 proposed coaching calls.
|
Wellness Control
n=11 participants at risk
WEllness for Longevity Living with MS (WELL)- Control Condition: The attention/contact wellness control condition will mirror the exercise training intervention condition, but focuses on implementing health behaviors other than physical activity (e.g., diet and emotional wellbeing). This program is an adapted version of the WellMS program from Prof. Motl's Phase III clinical trial (NCT03490240). The program is based on SCT principles of behavior change and integrates wellness resources from the National MS Society (NMSS). The research team has created 12 Newsletters that will be delivered on the same chat schedule as the exercise training intervention. All coaching chats and newsletters will occur with the same frequency as in the exercise training intervention condition. Participants will be provided with a participant manual, logbook, and calendar. Participants will work with their behavioral coach on goal setting specific to wellness behaviors.
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection (UTI) Hospitalization
|
8.3%
1/12 • Number of events 1 • up to 16 weeks
|
0.00%
0/11 • up to 16 weeks
|
|
Nervous system disorders
Cognitive Hospital
|
0.00%
0/12 • up to 16 weeks
|
9.1%
1/11 • Number of events 1 • up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain Cycling
|
8.3%
1/12 • Number of events 1 • up to 16 weeks
|
0.00%
0/11 • up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
X-ray Slip Disk
|
8.3%
1/12 • Number of events 1 • up to 16 weeks
|
0.00%
0/11 • up to 16 weeks
|
|
Nervous system disorders
Minor MS Exacerbation
|
0.00%
0/12 • up to 16 weeks
|
9.1%
1/11 • Number of events 1 • up to 16 weeks
|
|
Infections and infestations
Hospitalization
|
8.3%
1/12 • Number of events 1 • up to 16 weeks
|
0.00%
0/11 • up to 16 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1 • up to 16 weeks
|
0.00%
0/11 • up to 16 weeks
|
Additional Information
Stephanie L Silveira, PhD
The University of Texas Health Science Center at Houston
Phone: 713-500-9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place