Examining a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Feasibility and Initial Efficacy of a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888727
• Other study ID #: HSC-SPH-23-0719
• Secondary ID: R03HD107615
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Stephanie L Silveira, PhD
• Phone: 713-500-9000
• Email: Stephanie.L.Silveira[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized controlled clinical trial is to examine the feasibility and initial efficacy of undertaking and delivering a novel, stakeholder-informed exercise training program for wheelchair users with multiple sclerosis. The main questions it aims to answer are:

• Is the study feasible as measured by participant recruitment (24 participants total), retention (80%), and safety (adverse events)?

• Is the study acceptable as measured by participant satisfaction and perceptions using an evaluation survey and semi-structured interviews?

• Is there significant change in following the 16-week study in metabolic health outcomes, MS symptoms, and exercise behavior change? Participants will be randomized to complete the 16-week SPIN exercise training program or WellMS attention/contact wellness program.

Researchers will compare the SPIN and WellMS groups to determine if there is a significant difference in metabolic health outcomes, MS symptoms, and exercise behavior change.

Description:

The proposed study will use a randomized controlled design to examine the feasibility and initial efficacy of undertaking and delivering a novel, stakeholder-informed exercise training program for wheelchair users with MS compared with an attention/contact wellness control condition. Feasibility testing is essential for (a) learning if an intervention can be delivered and then (b) refining the approach before conducting an expensive, fully powered efficacy study. The primary outcome of interest is process and resource feasibility as measured by participant recruitment, retention, and safety. The secondary outcome of interest is acceptability, specifically participant satisfaction and perceptions, assessed through an evaluation survey and semi-structured interviews. The tertiary outcomes encompass scientific outcomes of interest for larger efficacy trials (i.e., metabolic health outcomes, MS symptoms, and exercise behavior change).

Twenty-four participants will be recruited and randomized to complete the 16-week SPIN exercise training program or WellMS attention/contact wellness program. Recruitment, screening, and enrollment will be completed by a graduate research assistant and the intervention will be delivered online by the PI through one-on-one behavioral coaching. Data regarding the primary, secondary, and tertiary outcomes will be collected at throughout the study period.

The proposed study includes three specific aims and hypotheses:

Specific Aim 1: Evaluate the feasibility (i.e., recruitment, retention, and safety) of an exercise training intervention and attention/contact wellness control condition delivered over a 16-week period in a sample of 24 adult wheelchair users with MS from the Dallas-Fort Worth Metroplex.

Hypothesis 1: The study protocol will be feasible in terms of reaching recruitment goals (n=24; 12 per group) within a one-year period, retaining 80% or more of those participants through the full 16-week study period, and safe in terms of <10% of participants reporting adverse events.

Specific Aim 2: Evaluate the acceptability (i.e., participant satisfaction and perceptions) of a 16-week exercise training intervention and attention/contact wellness control condition in a sample of 24 adult wheelchair users with MS from the Dallas-Fort Worth Metroplex.

Hypothesis 2: Participants in both conditions will report high satisfaction (mean rating 4/5 or greater) via formative evaluation surveys and positive perceptions regarding their assigned program via post-test interviews.

Specific Aim 3: Assess the scientific outcomes of interest (i.e., metabolic health, MS symptoms, and exercise behavior change) for determining effect size and sample size estimates in powering a future R01.

Hypothesis 3: The intervention exercise training program will lead to greater improvements in metabolic health outcomes (i.e., HbA1c, cholesterol, glucose, and triglycerides, MS symptoms (i.e., fatigue, pain, depression, and quality of life) and exercise behavior compared to the attention/control wellness program.

Procedures. All study procedures have been reviewed and approved by the University of North Texas Institutional Review Board. Interested participants will contact the graduate research assistant for a telephone screening, which includes a comprehensive description of the study followed by screening for inclusion criteria. Participants deemed eligible for the study will then be sent a consent form to review and sign using through DocuSign. When the graduate research assistant receives the signed consent form, participants will be mailed a pre-test/baseline assessment packet. The pre-test assessment packet will include Actigraph GT3X+ accelerometer and instructions to wear the accelerometer on the non-dominant wrist for 7 days as well as an order for blood sample collection at a Quest Diagnostics location that is convenient for them. Participants will complete a battery of questionnaires online using Qualtrics. When the graduate research assistant receives the accelerometer and notification that a blood sample has been collected, participants will be randomized using a random numbers sequence with concealed allocation (i.e., opaque sealed envelopes) by a member of the research team. Following randomization, participants will be mailed their condition-specific program materials as well as instructions for downloading Zoom. Participants will be provided an opportunity to complete technology training sessions prior to beginning the program to support individuals with limited digital literacy. Further, the research team will have 3 data-enabled devices for participants who lack hardware and/or Internet access. Post-test assessment of tertiary outcomes following the 16-week intervention will mirror baseline assessments. Participants will be asked to complete an additional evaluation questionnaire to assess satisfaction with the program and usability of intervention components. All participants will be invited to complete a post-test semi-structured interview via Zoom to provide feedback on their experiences and suggestions for refining the program. All participants will be compensated for completing each assessment, and an additional sum will be provided for those who complete the post-test interview.

Data Analyses. The analysis will use the intent-to-treat principle where participants will be analyzed in their randomization assignment. The focus of Specific Aims 1 & 2 is on feasibility of the study protocol. Descriptive statistics including frequencies and percentages will be used to assess Hypotheses 1 & 2. Hypothesis 2 is focused on equally favorable outcomes between conditions, which is important for guiding a future, larger efficacy study because if one condition is rated more favorably that would incorporate additional bias. If differences in feedback are identified, modifications to the appropriate condition will be made prior to fully-powered efficacy testing. The scientific outcomes in Hypothesis 3 (i.e., metabolic health outcomes, MS symptoms, and exercise behavior) will be examined using 2 time by 2 group mixed factor ANOVA with estimation of Cohen's d values for effect sizes. Participant's change in scientific outcomes will be further examined and compared with the >0.5 SD will be considered meaningful change based on benchmarks established in previous research.

Fidelity Monitoring. The research team is creating a fidelity monitoring protocol that aligns with the 5 domains outlined by the NIH Behavior Change Consortium adapted from a protocol led by the PI that was applied in a Phase-III clinical trial. The PI will serve as the behavioral coach given her experience as a behavioral coach in both physical activity and wellness conditions in 5 waves of the aforementioned clinical trial. The PI is not involved in outcome assessments and parallel scripts have been developed for each condition oriented toward the condition's content. The scripts include a check-in on the previous week, discussion of the week's Newsletter topic, and planning for the subsequent week. In line with our previous studies, randomly selected participant chats will be selected for fidelity monitoring to be completed; a Co-I will review the recorded session using a standard checklist to ensure systematic bias is not present.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of MS

• self-reported use of a wheelchair (i.e., manual wheelchair, power wheelchair, or scooter) >50% of the time

• age of 18 years or older

• relapse free for the past 30 days

• being non-active defined as not engaging in regular physical activity (30 minutes accumulated per day) on more than 2 days of the week during the previous 6 months (i.e., not meeting current physical activity guidelines for MS)

Exclusion Criteria:

• during telephone screening participants will complete an exercise pre-participation health screen and if participants report any symptoms or conditions contradictive of exercise then physician clearance will be required before enrollment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• 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 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Craig Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire	Physical 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.	16-weeks
Other	Change in Metabolic Health Outcomes: Triglycerides	Triglycerides 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.	16-weeks
Other	Change in Metabolic Health Outcomes: HbA1c	HbA1c 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.	16-weeks
Other	Change in Metabolic Health Outcomes: Cholesterol	Cholesterol 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.	16-weeks
Other	Change in Metabolic Health Outcomes: Glucose	Fasting 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.	16-weeks
Other	Adherence to assigned condition	We 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).	16-weeks
Other	Change in MS Symptoms: Fatigue	Fatigue 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.	16-weeks
Other	Change in MS Symptoms: Pain	Pain 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.	16-weeks
Other	Change in MS Symptoms: Depression	Depressive 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.	16-weeks
Other	Change in MS Symptoms: Quality of life	Quality 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.	16-weeks
Other	Change of Physical Activity levels through Accelerometery from baseline at 16 weeks	Physical 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.	16-weeks
Primary	Study Feasibility: Number of Participants Recruited	Feasibility of the intervention will be measured based on reaching recruitment goals (n=24) within a one-year period. All contacts between interested participants will be recorded in a REDCap database to assess recruitment.	16-weeks
Primary	Study Feasibility: Number of Participants Retained	Feasibility of the intervention will be measured based on retention of >80% of enrolled participants for the full 16-week study period. All contacts between enrolled participants will be recorded in a REDCap database to assess retention.	16-weeks
Primary	Study Feasibility: Incidence of Adverse Events	Feasibility of the intervention will be measured in terms of <10% of participants reporting adverse events. All contacts between enrolled participants will be recorded in a REDCap database to assess retention.	16-weeks
Secondary	Acceptability: Semi-structured interview	Acceptability of the intervention will be determined using semi-structured interviews. All participants will be invited to complete a post-test semi-structured interview online via Zoom with the graduate research assistant that will last 20-40 minutes. A standard interview guide will be used to provide a rich assessment of acceptability and suggestions for refining the exercise training program.	16-weeks
Secondary	Acceptability: Survey	Acceptability of the intervention will be determined using a post-test evaluation survey. Survey items will include Likert ratings of participant satisfaction with the program and utility of all condition-specific components (e.g., equipment and coaching) plus include open-ended questions where participants can report their preferred components and offer suggestions for improvement.	16-weeks