Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy
Primary Purpose
Muscular Dystrophies, Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cycle exercise
Sponsored by
About this trial
This is an interventional treatment trial for Muscular Dystrophies focused on measuring wheelchair, cycle exercise
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
Sites / Locations
- Copenhagen Neuromuscular Center, CNMC, depart. 8077Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Run-in period, patients with cerebral palsy or muscular dystrophy
Exercise period, patients with cerebral palsy or muscular dystrophy
Arm Description
10 weeks of no exercise
10 weeks of exercise
Outcomes
Primary Outcome Measures
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.
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.
Questionnaire on constipation
A questionnaire made from the Danish definition of constipation will be used. Four questions will be answered "yes" or "no".
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.
Secondary Outcome Measures
Blood sample
Change in blood sample for blood lipids, mmol/l
Blood sample
Change in blood sample for HbA1C, mmol/mol
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.
Ultrasound
Change in muscle cross sectional area in thigh, cm2
Ultrasound
Change in muscle fat fraction in thigh, %
Exercise test
Change in time it takes to cycle 1 km, minutes
Motorscore
Change in motor-score - MFM-32 (muscular dystrophy) or GMFM-88 (cerebral palsy)
Full Information
NCT ID
NCT04677010
First Posted
November 17, 2020
Last Updated
January 17, 2023
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04677010
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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.
to investigate if patients unable to move their legs will have effect of the training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies, Cerebral Palsy
Keywords
wheelchair, cycle exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
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.
Allocation
Non-Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Run-in period, patients with cerebral palsy or muscular dystrophy
Arm Type
No Intervention
Arm Description
10 weeks of no exercise
Arm Title
Exercise period, patients with cerebral palsy or muscular dystrophy
Arm Type
Active Comparator
Arm Description
10 weeks of exercise
Intervention Type
Other
Intervention Name(s)
Cycle exercise
Intervention Description
10 weeks of cycle exercise on a cycle ergometer with motor.
Primary Outcome Measure Information:
Title
Questionnaire on fatigue
Description
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.
Time Frame
5 minutes
Title
Questionnaire on pain.
Description
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.
Time Frame
5 minutes
Title
Questionnaire on constipation
Description
A questionnaire made from the Danish definition of constipation will be used. Four questions will be answered "yes" or "no".
Time Frame
5 minutes
Title
Questionnaire on quality of life, QOL
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Blood sample
Description
Change in blood sample for blood lipids, mmol/l
Time Frame
5 minutes
Title
Blood sample
Description
Change in blood sample for HbA1C, mmol/mol
Time Frame
5 minutes
Title
Blood sample
Description
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.
Time Frame
5 minutes
Title
Ultrasound
Description
Change in muscle cross sectional area in thigh, cm2
Time Frame
20 minutes
Title
Ultrasound
Description
Change in muscle fat fraction in thigh, %
Time Frame
20 minutes
Title
Exercise test
Description
Change in time it takes to cycle 1 km, minutes
Time Frame
30 minutes
Title
Motorscore
Description
Change in motor-score - MFM-32 (muscular dystrophy) or GMFM-88 (cerebral palsy)
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nanna S Poulsen, MD
Phone
+45 3545 4346
Email
Nanna.scharff.poulsen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanna S Poulsen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen Neuromuscular Center, CNMC, depart. 8077
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nanna S Poulsen, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29779596
Citation
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.
Results Reference
background
PubMed Identifier
15145637
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.
Results Reference
background
PubMed Identifier
28936414
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.
Results Reference
background
PubMed Identifier
2691827
Citation
Glaser RM. Arm exercise training for wheelchair users. Med Sci Sports Exerc. 1989 Oct;21(5 Suppl):S149-57.
Results Reference
background
PubMed Identifier
22938881
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.
Results Reference
background
PubMed Identifier
32611642
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.
Results Reference
background
PubMed Identifier
18295624
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.
Results Reference
background
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Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy
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