Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy

NCT04677010 | Completed DMC

• 1 other identifier: H-20075272
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscular Dystrophies; Cerebral Palsy

Keywords

wheelchair; cycle exercise

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• Blood sample

  5 minutes

• Blood sample

  5 minutes

• Blood sample

  5 minutes

• Ultrasound

  20 minutes

• Ultrasound

  20 minutes

Study Arms (2)

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

NO INTERVENTION

10 weeks of no exercise

Exercise period, patients with cerebral palsy or muscular dystrophy

ACTIVE COMPARATOR

10 weeks of exercise

Other: Cycle exercise

Interventions

Cycle exercise OTHER

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

Exercise period, patients with cerebral palsy or muscular dystrophy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen Neuromuscular Center, CNMC, depart. 8077

Copenhagen, 2100, Denmark

Location

Related 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.

  PMID: 29779596 BACKGROUND

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

  PMID: 15145637 BACKGROUND

• 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.

  PMID: 28936414 BACKGROUND

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

  PMID: 2691827 BACKGROUND

• 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.

  PMID: 22938881 BACKGROUND

• 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.

  PMID: 32611642 BACKGROUND

• 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.

  PMID: 18295624 BACKGROUND

MeSH Terms

Conditions

Muscular Dystrophies; Cerebral Palsy

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nanna S Poulsen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 21, 2020
• Study Start: June 1, 2021
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

DK (1)