Clinical trial NCT05888727: Examining a Wheelchair Exercise-training Intervention for Persons with Multiple Sclerosis
Official title: Feasibility and Initial Efficacy of a Wheelchair Exercise-training Intervention for Persons with Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: Craig Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-06-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Study Feasibility: Number of Participants Recruited
timeFrame: 16-weeks
measure: Study Feasibility: Number of Participants Retained
timeFrame: 16-weeks
measure: Study Feasibility: Incidence of Adverse Events
timeFrame: 16-weeks
Secondary outcomes:
measure: Acceptability: Semi-structured interview
timeFrame: 16-weeks
measure: Acceptability: Survey
timeFrame: 16-weeks
Other outcomes:
measure: Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire
timeFrame: 16-weeks
measure: Change in Metabolic Health Outcomes: Triglycerides
timeFrame: 16-weeks
measure: Change in Metabolic Health Outcomes: HbA1c
timeFrame: 16-weeks
measure: Change in Metabolic Health Outcomes: Cholesterol
timeFrame: 16-weeks
measure: Change in Metabolic Health Outcomes: Glucose
timeFrame: 16-weeks
measure: Adherence to assigned condition
timeFrame: 16-weeks
measure: Change in MS Symptoms: Fatigue
timeFrame: 16-weeks
measure: Change in MS Symptoms: Pain
timeFrame: 16-weeks
measure: Change in MS Symptoms: Depression
timeFrame: 16-weeks
measure: Change in MS Symptoms: Quality of life
timeFrame: 16-weeks
measure: Change of Physical Activity levels through Accelerometery from baseline at 16 weeks
timeFrame: 16-weeks
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Stephanie L Silveira, PhD
role: PRINCIPAL_INVESTIGATOR
References: