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

NCT ID: NCT01895283

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Moderate-intensity training

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

Group Type: EXPERIMENTAL

Moderate-intensity training

Intervention Type: BEHAVIORAL

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

Interventions

Moderate-intensity training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with Bethlem myopathy

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Christoffer Rasmus Vissing

BsC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoffer R Vissing, BsC

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Neuromuscular Research Unit

Locations

Rigshospitalet, Neuromuscular Research Unit, section 3342

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-2-2013-066

Identifier Type: -

Identifier Source: org_study_id