High Intensity Training in Patients With Facioscapulohumeral Muscular Dystrophy (HIT-FSHD)
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|ClinicalTrials.gov Identifier: NCT02159963|
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : April 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|FSHD - Facioscapulohumeral Muscular Dystrophy||Other: Supervised training Other: Unsupervised training Other: Optional training Other: Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||High Intensity Interval Training in Patients With Facioscapulohumeral Muscular Dystrophy|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Supervised training
8 weeks of high intensity training three times a week, once supervised. Followed by 8 weeks home based, unsupervised optional training.
Other: Supervised training
8 weeks high intensity interval training, 3 times a week, one is supervised, two are home based unsupervised.
Other: Optional training
8 weeks of optional home based, unsupervised training.
Experimental: Unsupervised training
Participants have 8 weeks of non-intervention "Control" period, followed by 8 weeks of home based, unsupervised high intensity interval training.
Other: Unsupervised training
8 weeks home based high-intensity-interval cycle-training 3 times a week.
8 weeks of control period. Participants are doing daily living.
- 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.
- 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.
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159963
|Copenhagen Neuromuscular Center, department of Neurology, Rigshospitalet|
|Copenhagen, Denmark, DK-2100|