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Trial record 7 of 33 for:    FSHD

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
Sponsor:
Information provided by (Responsible Party):
Grete Andersen, MD, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
FSHD - Facioscapulohumeral Muscular Dystrophy Other: Supervised training Other: Unsupervised training Other: Optional training Other: Control Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
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


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.
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.

Other: Control
8 weeks of control period. Participants are doing daily living.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
Denmark
Copenhagen Neuromuscular Center, department of Neurology, Rigshospitalet
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Grete Andersen, MD

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Grete Andersen, MD, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02159963     History of Changes
Other Study ID Numbers: H-4-2014-035 (FSH)
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016

Keywords provided by Grete Andersen, MD, Rigshospitalet, Denmark:
FSHD
HIT
Training
Exercise
10-20-30 interval training

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn