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Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy

Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04677010
Enrollment
33
Registered
2020-12-21
Start date
2021-06-01
Completion date
2024-05-21
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Dystrophies, Cerebral Palsy

Keywords

wheelchair, cycle exercise

Brief summary

Wheelchair bound patients often have pain in lower back and glutes, constipation and reduced quality of life - symptoms that exercise might ameliorate. However, in wheelchair bound patients with muscular dystrophies and cerebral palsy only very little research is done on exercise. We thus wish to investigate effects of cycle exercise in wheelchair bound patients with muscular dystrophy and cerebral palsy.

Detailed description

Wheelchair bound patients with MD or CP live a sedentary life, and probably because of this, many experience pain in lower back and glutes, obstipation, reduced quality of life, reduced activity of daily living and social withdrawal. Exercise is likely to reduce these symptoms. However, research in exercising patients confined to a wheelchair lacks 3 things: 1) Most research is done in patients that are wheelchair bound due to stroke, and these results are not necessarily transferable to patients with MD or CP. Patients with stroke differ from patients with MD and CP since they can potentially gain walking ability again, they have had walking ability up to the stroke, they are only hemiparetic and thus have normal function in the rest of the body, their muscles are atrophic but otherwise healthy and they have no contractures. 2) Most research in exercise in patients with MD or CP focuses on preventing patients from being wheelchair bound - only very little research is done in the most severely affected patients that are wheelchair bound, although many of their symptoms can potentially be ameliorated by exercise. 3) To date, research in exercise in wheelchair bound patients with MD or CP has primarily consisted of arm cycling. It has been shown to reduce BMI and improve cardiorespiratory status, endurance, muscle strength and activities of daily living, but not without complications. The upper limbs consist of small muscle groups that are easily fatigued and therefore proper cardiopulmonary fitness is difficult to obtain. The risk of upper limb overuse injuries is high, reducing patients function and activities of daily living. Presently, there is no feasible and acceptable way to exercise for this large patient group. The investigators have tested a cycle ergometer for the lower limbs that can be used while the patients sit in their own wheelchair. It has a motor, since most patients are not able to turn the pedals themselves, and a sensor that can measure how much patients contribute to cycling. They have tested 3 wheelchair bound patients. After training, they all experienced reduced pain in lower back and glutes, less obstipation and increased energy. Surprisingly, the heart rate increased during exercise by up to 65 beats even in patients that could not turn the pedals themselves, indicating cardiovascular fitness. To test this form of exercise in a larger group of patients that are wheelchair bound due to MD or CP will be of great interest. The aim of this project is thus: 1. to test a cycle ergometer for lower limbs in patients who are wheelchair bound due to MD or CP to find a feasible and acceptable way to exercise in order to increase health and quality of life. 2. to investigate if patients unable to move their legs will have effect of the training.

Interventions

10 weeks of cycle exercise on a cycle ergometer with motor.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Statistics will be made by an investigator blinded to what results are from before, in-between and after the two periods of rest and exercise respectively.

Intervention model description

One group consisting of patients with either cerebral palsy or muscular dystrophy will do a 10 weeks run-in period with no exercise immediately followed by 10 weeks of exercise. They will be testet before and after the run-in period and after the exercise period.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Verified muscular dystrophy or cerebral palsy * Age: Over 18 years * Wheelchair use; can at maximum stand up for transfers and is unable to walk for more than 5 meters.

Exclusion criteria

* Competing disorders (as arthritis) or other muscle disorders * Unable to use the cycle ergometer due to contractures

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire on quality of life, QOL10 minutesA QOL that has been used in former studies will be used. 16 questions with scores ranging from 1 (very unsatisfied) to 7 (very satisfied) will be scored.
Questionnaire on fatigue5 minutesThe FSS (fatigue severity scale) will be used. Scores range from 1 to 7 with a total maximum score at 63. Lower scores mean less fatigue.
Questionnaire on pain.5 minutesA visual pain score that has been used in former studies with 3 questions with scores ranging from 1 to 10 each, 10 being the worst pain imaginable, will be used.
Questionnaire on constipation5 minutesA questionnaire made from the Danish definition of constipation will be used. Four questions will be answered yes or no.

Secondary

MeasureTime frameDescription
Blood sample5 minutesChange in blood sample for blood lipids, mmol/l
Ultrasound20 minutesChange in muscle cross sectional area in thigh, cm2
Exercise test30 minutesChange in time it takes to cycle 1 km, minutes
Motorscore30 minutesChange in motor-score - MFM-32 (muscular dystrophy) or GMFM-88 (cerebral palsy)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026