Participate in a Clinical Trial
Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.
The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis
Study Purpose
There is ample evidence that regular exercise can reduce MS specific symptoms and improve health and wellbeing in people with MS. However, for people with MS to engage in exercise activities long term, it is important that they are offered a range of exercise opportunities that are safe, feasible and potentially effective to reduce MS symptom. This will allow people to select an activity they enjoy, is adapted to their needs and thus are more sustainable long-term. Frame Running (FR) provides an opportunity for people with walking and balance problems to walk or run safely without the risk of falling. The frame consists of three wheels and has a saddle and handlebars like a trike without pedals. The proposed mixed methods study aims to examine the feasibility and acceptability of FR as a sustainable aerobic exercise option for people with MS and the feasibility of conducting a future definite trial into the impact of FR on functional mobility, fatigue, cardiorespiratory function and psychosocial outcomes. People who experience problems with their walking and/or balance will be eligible to take part in this study which consists of a 12 weekly group FR training sessions led by a qualified coach. FR training attendance, recruitment, retention, outcome measure completion and adverse events will be recorded and the participant views on the feasibility, acceptability and impact of FR will be explored through the use of focus groups. Physical function, physical activity and psychosocial outcomes will be assessed at baseline, 6 and 12 weeks.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05234879 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Queen Margaret University |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Marietta L van der Linden, PhD |
Principal Investigator Affiliation | Queen Margaret University |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | United Kingdom |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Sclerosis |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Posting a Trial
If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.