Clinical trial NCT04677010: Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy
Official title: Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophies
Cerebral Palsy
Keywords: wheelchair
cycle exercise
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Questionnaire on fatigue
timeFrame: 5 minutes
measure: Questionnaire on pain.
timeFrame: 5 minutes
measure: Questionnaire on constipation
timeFrame: 5 minutes
measure: Questionnaire on quality of life, QOL
timeFrame: 10 minutes
Secondary outcomes:
measure: Blood sample
timeFrame: 5 minutes
measure: Blood sample
timeFrame: 5 minutes
measure: Blood sample
timeFrame: 5 minutes
measure: Ultrasound
timeFrame: 20 minutes
measure: Ultrasound
timeFrame: 20 minutes
measure: Exercise test
timeFrame: 30 minutes
measure: Motorscore
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Neuromuscular Center, CNMC, depart. 8077
Study officials:
affiliation: Rigshospitalet, Denmark
name: Nanna S Poulsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dahlqvist JR, Poulsen NS, Ostergaard ST, Fornander F, de Stricker Borch J, Danielsen ER, Thomsen C, Vissing J. Evaluation of inflammatory lesions over 2 years in facioscapulohumeral muscular dystrophy. Neurology. 2020 Sep 1;95(9):e1211-e1221. doi: 10.1212/WNL.0000000000010155. Epub 2020 Jul 1.
citation: Janssen TW, Beltman JM, Elich P, Koppe PA, Konijnenbelt H, de Haan A, Gerrits KH. Effects of electric stimulation-assisted cycling training in people with chronic stroke. Arch Phys Med Rehabil. 2008 Mar;89(3):463-9. doi: 10.1016/j.apmr.2007.09.028.