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NCT Number: NCT02159963

High Intensity Training in Patients With Facioscapulohumeral Muscular Dystrophy

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.

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Key information

Conditions

FSHD - Facioscapulohumeral Muscular Dystrophy Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Motor Activity Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Facioscapulohumeral Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen Neuromuscular Center, department of Neurology, Rigshospitalet

Copenhagen, DK-2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Supervised training

Other

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

Unsupervised training

Other

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

Optional training

Other

8 weeks of optional home based, unsupervised training.

Control

Other

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

Primary outcomes

  1. Incremental test

    Time frame: week 1,6,11 and 18

    An incremental test is performed at baseline (week 1), after 4 weeks interval training, in the end of 8 weeks interval training, and after another 8 week of individual home based training. The primary outcome is change from baseline in maximal oxygen consumption and work load.

Secondary outcomes

  1. Physical function

    Time frame: baseline, week 6,11 and 18

    We measure changes from baseline in muscle strength, walking speed and the ability to rise up from a chair.

    Muscle strength is measured by a hand-held dynamometer. Walking speed is measured by a 6 minute walk test. The ability to rise up from a chair is measured by a 5-times-sit-to-stand-test.

  2. Self-assessment

    Time frame: Every day in week 1-11

    Changes between run-in period (week 1-2) and the first intervention period (week 3-11).

    Participants evaluate pain, muscle fatigue and daily activity level every day using a visual analog scale (VAS).

  3. Creatine Kinase

    Time frame: week 1,6,11 and 18

    Creatine Kinase (CK) is measure in plasma at week 1,6,11 and 18 in all participants. In the supervised training participants CK is also measured once a week doing the 8 weeks of supervised training.

  4. Activity level

    Time frame: baseline, week 10 and week 18.

    Change in activity level from baseline is measure as step/day. Participants is wearing a pedometer for seven days.

Sponsors and collaborators

Lead sponsor

Grete Andersen, MD

Other

Registry information

Official study title

High Intensity Interval Training in Patients With Facioscapulohumeral Muscular Dystrophy

Acronym: HIT-FSHD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2014
Registry last updated
Apr 25, 2016

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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