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Behavioural Intervention
Wheelchair Exercise Training for Multiple Sclerosis
N/A
Recruiting
Led By Stephanie L Silveira, PhD
Research Sponsored by University of North Texas, Denton, TX
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16-weeks
Awards & highlights
Summary
This trial studies the effectiveness of an exercise training program for wheelchair-users with MS, to see if it can improve metabolic health, MS symptoms and exercise behavior.
Who is the study for?
This trial is for adults over 18 with Multiple Sclerosis who are mostly wheelchair users and not currently active, meaning they don't do regular physical activity more than twice a week. They must have been relapse-free for the last month and will need a doctor's okay if there are health concerns that usually suggest exercise isn't safe.
What is being tested?
The study tests a new exercise program called SPIN against a wellness program named WellMS in people with MS using wheelchairs. It looks at how well these programs work by checking participant numbers, satisfaction, safety, changes in metabolic health, MS symptoms, and whether participants stick to exercising after the 16-week course.
What are the potential side effects?
Since this trial involves exercise programs rather than medication or medical procedures, side effects may include typical responses to new physical activities such as muscle soreness or fatigue. Any serious adverse events related to the exercises would be closely monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16-weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Study Feasibility: Incidence of Adverse Events
Study Feasibility: Number of Participants Recruited
Study Feasibility: Number of Participants Retained
Secondary study objectives
Acceptability: Semi-structured interview
Acceptability: Survey
Other study objectives
Adherence to assigned condition
Change in MS Symptoms: Depression
Change in MS Symptoms: Fatigue
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise Training InterventionExperimental Treatment1 Intervention
Group II: Wellness ControlActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of North Texas, Denton, TXLead Sponsor
10 Previous Clinical Trials
6,867 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
33 Patients Enrolled for Multiple Sclerosis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,810 Total Patients Enrolled
18 Trials studying Multiple Sclerosis
1,784 Patients Enrolled for Multiple Sclerosis
Craig HospitalOTHER
41 Previous Clinical Trials
8,395 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
178 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I passed a health screen for exercise or have doctor's clearance.I have been diagnosed with multiple sclerosis (MS).I use a wheelchair more than half of the time.I have not had a relapse in the last 30 days.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Training Intervention
- Group 2: Wellness Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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