Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677010
• Other study ID #: H-20075272
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Nanna S Poulsen, MD
• Phone: +45 3545 4346
• Email: Nanna.scharff.poulsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscular Dystrophies

Intervention

Other:
• Cycle exercise
10 weeks of cycle exercise on a cycle ergometer with motor.

Locations

Country	Name	City	State
Denmark	Copenhagen Neuromuscular Center, CNMC, depart. 8077	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

Carter JC, Sheehan DW, Prochoroff A, Birnkrant DJ. Muscular Dystrophies. Clin Chest Med. 2018 Jun;39(2):377-389. doi: 10.1016/j.ccm.2018.01.004. — View 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. — View Citation

Ellapen TJ, Hammill HV, Swanepoel M, Strydom GL. The health benefits and constraints of exercise therapy for wheelchair users: A clinical commentary. Afr J Disabil. 2017 Sep 8;6:337. doi: 10.4102/ajod.v6i0.337. eCollection 2017. — View Citation

Glaser RM. Arm exercise training for wheelchair users. Med Sci Sports Exerc. 1989 Oct;21(5 Suppl):S149-57. — View 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. — View Citation

Koman LA, Smith BP, Shilt JS. Cerebral palsy. Lancet. 2004 May 15;363(9421):1619-31. doi: 10.1016/S0140-6736(04)16207-7. — View Citation

Skalsky AJ, McDonald CM. Prevention and management of limb contractures in neuromuscular diseases. Phys Med Rehabil Clin N Am. 2012 Aug;23(3):675-87. doi: 10.1016/j.pmr.2012.06.009. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire on fatigue	The 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.	5 minutes
Primary	Questionnaire on pain.	A 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.	5 minutes
Primary	Questionnaire on constipation	A questionnaire made from the Danish definition of constipation will be used. Four questions will be answered "yes" or "no".	5 minutes
Primary	Questionnaire on quality of life, QOL	A 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.	10 minutes
Secondary	Blood sample	Change in blood sample for blood lipids, mmol/l	5 minutes
Secondary	Blood sample	Change in blood sample for HbA1C, mmol/mol	5 minutes
Secondary	Blood sample	Change in blood sample for Creatine kinase, U/I. This will be monitored before, in the middle and after the exercise period as a safety measure.	5 minutes
Secondary	Ultrasound	Change in muscle cross sectional area in thigh, cm2	20 minutes
Secondary	Ultrasound	Change in muscle fat fraction in thigh, %	20 minutes
Secondary	Exercise test	Change in time it takes to cycle 1 km, minutes	30 minutes
Secondary	Motorscore	Change in motor-score - MFM-32 (muscular dystrophy) or GMFM-88 (cerebral palsy)	30 minutes