- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02159963
High Intensity Training in Patients With Facioscapulohumeral Muscular Dystrophy (HIT-FSHD)
High Intensity Interval Training in Patients With Facioscapulohumeral Muscular Dystrophy
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, DK-2100
- Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supervised training
8 weeks of high intensity training three times a week, once supervised.
Followed by 8 weeks home based, unsupervised optional training.
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8 weeks high intensity interval training, 3 times a week, one is supervised, two are home based unsupervised.
8 weeks of optional home based, unsupervised training.
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Experimental: Unsupervised training
Participants have 8 weeks of non-intervention "Control" period, followed by 8 weeks of home based, unsupervised high intensity interval training.
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8 weeks home based high-intensity-interval cycle-training 3 times a week.
8 weeks of control period.
Participants are doing daily living.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental test
Time Frame: week 1,6,11 and 18
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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.
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week 1,6,11 and 18
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical function
Time Frame: baseline, week 6,11 and 18
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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. |
baseline, week 6,11 and 18
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Self-assessment
Time Frame: Every day in week 1-11
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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). |
Every day in week 1-11
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Creatine Kinase
Time Frame: week 1,6,11 and 18
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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.
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week 1,6,11 and 18
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Activity level
Time Frame: baseline, week 10 and week 18.
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Change in activity level from baseline is measure as step/day.
Participants is wearing a pedometer for seven days.
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baseline, week 10 and week 18.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-4-2014-035 (FSH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on FSHD - Facioscapulohumeral Muscular Dystrophy
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aTyr Pharma, Inc.CompletedFacioscapulohumeral Muscular Dystrophy (FSHD)United States, Netherlands, France, Italy
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Hoffmann-La RocheActive, not recruitingFacioscapulohumeral Muscular Dystrophy (FSHD)United States, United Kingdom, Italy, Denmark
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Fulcrum TherapeuticsActive, not recruitingFacioscapulohumeral Muscular Dystrophy (FSHD)United States, Spain, Italy, Denmark, Canada, Germany, France, Netherlands, United Kingdom
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Fulcrum TherapeuticsActive, not recruitingFacioscapulohumeral Muscular Dystrophy (FSHD)United States, Canada, France, Spain
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Fulcrum TherapeuticsCompletedFacioscapulohumeral Muscular Dystrophy (FSHD)United States, Canada, France, Spain
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aTyr Pharma, Inc.CompletedFacioscapulohumeral Muscular Dystrophy (FSHD)United States, France, Italy
-
Avidity Biosciences, Inc.RecruitingPhase 1/2 Study of AOC 1020 in Adults With Facioscapulohumeral Muscular Dystrophy (FSHD) (FORTITUDE)Muscular Dystrophies | Muscular Dystrophy, Facioscapulohumeral | FSHD | Facio-Scapulo-Humeral Dystrophy | FMD | Facioscapulohumeral Muscular Dystrophy 1 | FSHD2 | FSHD1 | FMD2 | Fascioscapulohumeral Muscular Dystrophy | Fascioscapulohumeral Muscular Dystrophy Type 1 | Fascioscapulohumeral Muscular Dystrophy... and other conditionsUnited States, United Kingdom, Canada
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Grete Andersen, MDCompletedFSHD - Facioscapulohumeral Muscular DystrophyDenmark
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Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
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University Hospital, MontpellierTerminatedPrimary Disease Facioscapulohumeral Dystrophy (FSHD)France
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