Clinical trial NCT02159963: High Intensity Training in Patients With Facioscapulohumeral Muscular Dystrophy
Official title: High Intensity Interval Training in Patients With Facioscapulohumeral Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: FSHD - Facioscapulohumeral Muscular Dystrophy
Keywords: FSHD
HIT
Training
Exercise
10-20-30 interval training
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Incremental test
timeFrame: week 1,6,11 and 18
Secondary outcomes:
measure: Physical function
timeFrame: baseline, week 6,11 and 18
measure: Self-assessment
timeFrame: Every day in week 1-11
measure: Creatine Kinase
timeFrame: week 1,6,11 and 18
measure: Activity level
timeFrame: baseline, week 10 and week 18.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Neuromuscular Center, department of Neurology, Rigshospitalet
Study officials:
References:
citation: 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.