Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy

NCT ID: NCT04677010

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-05-21

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.

Conditions

Muscular Dystrophies; Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Run-in period, patients with cerebral palsy or muscular dystrophy

10 weeks of no exercise

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise period, patients with cerebral palsy or muscular dystrophy

10 weeks of exercise

Group Type: ACTIVE_COMPARATOR

Cycle exercise

Intervention Type: OTHER

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

Interventions

Cycle exercise

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Nanna Scharff Poulsen

MD, PhD-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nanna S Poulsen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Copenhagen Neuromuscular Center, CNMC, depart. 8077

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 29779596 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 15145637 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28936414 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 2691827 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22938881 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32611642 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18295624 (View on PubMed)

Other Identifiers

H-20075272

Identifier Type: -

Identifier Source: org_study_id