High Intensity Training in Patients With Facioscapulohumeral Muscular Dystrophy

NCT ID: NCT02159963

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-09-30

Brief Summary

The investigators aim to investigate the effect of high-intensity training in patients with facioscapulohumeral muscular dystrophy. Can patients benefit from this type of exercise without muscle damage.

Detailed Description

Clinical trials have in recent years demonstrated that aerobic exercise, are both effective and safe in patients with facioscapulohumeral muscular dystrophy. Previous studies have tested exercise at moderate intensity. No studies have so far investigated whether high-intensity-training (HIIT) exercise can increase fitness, or the training will cause muscle damage. However, we know that patients with facioscapulohumeral muscular dystrophy do not get increased muscle damage after a single exercise at high intensity.

Investigators aim to investigate whether patients with facioscapulohumeral muscular disease may increase their fitness and improve their functioning in everyday life without muscle injury in a time-saving high intensity training.

To investigate whether HIIT is safe and effective, three groups of participants are included. Two training groups, one group of patients and another with healthy matched subjects. The training is done on an ergometer-bike three times a week for 8 weeks. One weekly training will be supervised. The training consists of an interval training program (10-20-30). The third group is a none-training control group of patients. This group will undergo the same tests as the two training groups.

To investigate wether participants would continue HIIT training after 8 weeks of supervised training, the two training groups, one group of patients and one group of healthy matched subjects, are tested after additional 8 weeks of home based optional training.

To investigate wether patients with muscular dystrophy facioscapulohumeral will perform unsupervised HIIT training and whether it will be as effective as the supervised training, the control group of patients who did not train the first 8 weeks, is instructed to do home based HIIT for 8 weeks.

Conditions

FSHD - Facioscapulohumeral Muscular Dystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supervised training

8 weeks of high intensity training three times a week, once supervised. Followed by 8 weeks home based, unsupervised optional training.

Group Type: EXPERIMENTAL

Supervised training

Intervention Type: OTHER

8 weeks high intensity interval training, 3 times a week, one is supervised, two are home based unsupervised.

Optional training

Intervention Type: OTHER

8 weeks of optional home based, unsupervised training.

Unsupervised training

Participants have 8 weeks of non-intervention "Control" period, followed by 8 weeks of home based, unsupervised high intensity interval training.

Group Type: EXPERIMENTAL

Unsupervised training

Intervention Type: OTHER

8 weeks home based high-intensity-interval cycle-training 3 times a week.

Control

Intervention Type: OTHER

8 weeks of control period. Participants are doing daily living.

Interventions

Supervised training

8 weeks high intensity interval training, 3 times a week, one is supervised, two are home based unsupervised.

Intervention Type: OTHER

Unsupervised training

8 weeks home based high-intensity-interval cycle-training 3 times a week.

Intervention Type: OTHER

Optional training

8 weeks of optional home based, unsupervised training.

Intervention Type: OTHER

Control

8 weeks of control period. Participants are doing daily living.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with Facioscapulohumeral muscular dystrophy or
• healthy matched control, matched for age, gender, BMI and activity level.

Exclusion Criteria

• More than 1 hour cardiac exercise weekly before inclusion.
• Pregnant or breastfeeding women.
• Physical or mental condition, which could influence the results.
• Participating in other studies, which could influence the results.
• Physical or mental condition, which prevent participating in the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Grete Andersen, MD

OTHER

Sponsor Role: lead

Responsible Party

Grete Andersen, MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Copenhagen Neuromuscular Center, department of Neurology, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

Andersen G, Hedermann G, Witting N, Duno M, Andersen H, Vissing J. The antimyotonic effect of lamotrigine in non-dystrophic myotonias: a double-blind randomized study. Brain. 2017 Sep 1;140(9):2295-2305. doi: 10.1093/brain/awx192.

Reference Type: DERIVED

PMID: 29050397 (View on PubMed)

Related Links

http://neuromuscular.dk

The Neuromuscular research units web-side

Other Identifiers

H-4-2014-035 (FSH)

Identifier Type: -

Identifier Source: org_study_id