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NCT Number: NCT04677010

Cycle Exercise in Wheelchair Users With Muscular Dystrophy or Cerebral Palsy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen Neuromuscular Center, CNMC, depart. 8077

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cycle exercise

Other

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

Primary outcomes

  1. Questionnaire on fatigue

    Time frame: 5 minutes

    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.

  2. Questionnaire on pain.

    Time frame: 5 minutes

    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.

  3. Questionnaire on constipation

    Time frame: 5 minutes

    A questionnaire made from the Danish definition of constipation will be used. Four questions will be answered "yes" or "no".

  4. Questionnaire on quality of life, QOL

    Time frame: 10 minutes

    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 outcomes

  1. Blood sample

    Time frame: 5 minutes

    Change in blood sample for blood lipids, mmol/l

  2. Blood sample

    Time frame: 5 minutes

    Change in blood sample for HbA1C, mmol/mol

  3. Blood sample

    Time frame: 5 minutes

    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.

  4. Ultrasound

    Time frame: 20 minutes

    Change in muscle cross sectional area in thigh, cm2

  5. Ultrasound

    Time frame: 20 minutes

    Change in muscle fat fraction in thigh, %

  6. Exercise test

    Time frame: 30 minutes

    Change in time it takes to cycle 1 km, minutes

  7. Motorscore

    Time frame: 30 minutes

    Change in motor-score - MFM-32 (muscular dystrophy) or GMFM-88 (cerebral palsy)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2020
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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