The Effect of Aerobic Exercise, on Fitness and Functional Muscle Strength, in Patients With Muscular Dystrophy

NCT01895283 | Completed DMC

• 1 other identifier: H-2-2013-066
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Muscular dystrophy is a group of disorders that are characterized by progressive muscle weakening and loss of muscle mass, caused by defects in muscle proteins. Muscular dystrophy is almost always inherited disorders, and so far, no curative treatments exist. Previous studies have shown that endurance training significantly improves fitness and self-assessed muscle function in a variety of muscular dystrophies. In this study, we wish to investigate whether patients with Bethlem myopathy (a specific form of muscular dystrophy) also benefit from endurance training. The study consists of two test days, a 10-week training period and five blood tests. Patients will be required to train, three times per week, for 10 weeks, on a bike ergometer with a specific training intensity, under pulse rate monitoring. The training period will be flanked by two test days, where we will determine, and compare the patients' muscle strength and fitness level, from before to after the training program. The patients conditioning level will be determined from a 15 minute cycle ergometer test and patients will undergo three functional tests to determine their functional muscle strength. We will as a safety measure analyze blood tests before, during and after the training program for the muscle enzyme creatine kinase (an indicator of muscle damage) and through adverse effects as reported by patients during weekly telephone-consultations with the Principal investigator. We anticipate, that Bethlem myopathy patients will have a similar rise in fitness level and functional muscle strength, as that seen in patients with other forms of muscular dystrophy, who undertake a similar training program.

Conditions

Bethlem Myopathy

Keywords

Aerobic training; VO2max; Bethlem myopathy

Outcome Measures

Primary Outcomes (1)

• Maximal oxygen uptake (VO2max)

  VO2max will be determined during an incremental bike test to exhaustion. VO2max is a physiological measure of physical fitness. VO2max relies on a persons ability to supply and consume oxygen ("energy") in muscle tissue.

  after 10 week bike ergometer training program

Secondary Outcomes (4)

• Functional muscle strength

  After completion of a 10 week training program

• Muscle strength determined by dynamometry

  After completion of a 10 week training program

• Self-assessed improvements in muscle function

  After completion of a 10 week training program

• Self-assessed improvements in incidence of problems that are related to inactivity (in patients who are confined to a wheel-chair)

  After a 10 week training program

Other Outcomes (1)

• Safety

  During a 10 week training program

Study Arms (1)

Moderate-intensity training

EXPERIMENTAL

Regular supervised moderate-intensity training on a bike ergometer, three times per week, for 30 minutes a total of 10 weeks.

Behavioral: Moderate-intensity training

Interventions

Moderate-intensity training BEHAVIORAL

Training at 70% of VO2max, for 1/2 hour, three times weekly, for 10 weeks, on a bike ergometer.

Moderate-intensity training

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Bethlem myopathy

You may not qualify if:

• Patients with disorders that would confound the interpretation of the effect from training (cardiomyopathy, pregnant women, etc.)
• Patients who are deemed mentally unfit for cooperation with the training program

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Neuromuscular Research Unit, section 3342

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Bethlem myopathy

Study Officials

• Christoffer R Vissing, BsC

  Rigshospitalet, Neuromuscular Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BsC

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

DK (1)