FSHD - Facioscapulohumeral Muscular DystrophyHIT-FSHDNCT02159963
High Intensity Training in Patients With Facioscapulohumeral Muscular Dystrophy
A study testing Supervised training, Unsupervised training and Optional training in people with FSHD - Facioscapulohumeral Muscular Dystrophy, run by Grete Andersen, MD at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- FSHD - Facioscapulohumeral Muscular Dystrophy
- What is being tested?
- Supervised training, Unsupervised training and Optional training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with Facioscapulohumeral muscular dystrophy or
- healthy matched control, matched for age, gender, BMI and activity level.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Neuromuscular Center, department of Neurology, Rigshospitalet
Copenhagen, DK-2100
About this study
Official title: High Intensity Interval 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.
Read the 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.
- Being tested
- Supervised training, Unsupervised training, Optional training, Control
- Keywords
- FSHD, HIT, Training, Exercise, 10-20-30 interval training
- Medical subject headings
- Muscular Dystrophy, Facioscapulohumeral, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised trainingOther
8 weeks high intensity interval training, 3 times a week, one is supervised, two are home based unsupervised.
Unsupervised trainingOther
8 weeks home based high-intensity-interval cycle-training 3 times a week.
Optional trainingOther
8 weeks of optional home based, unsupervised training.
ControlOther
8 weeks of control period. Participants are doing daily living.
| Study group | Role | What they receive |
|---|---|---|
| Supervised training | Experimental | 8 weeks of high intensity training three times a week, once supervised. Followed by 8 weeks home based, unsupervised optional training. Receives: Other: Supervised training; Other: Optional training |
| Unsupervised training | Experimental | Participants have 8 weeks of non-intervention "Control" period, followed by 8 weeks of home based, unsupervised high intensity interval training. Receives: Other: Unsupervised training; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental test
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.
Measured: week 1,6,11 and 18
Secondary outcomes (4)
Physical function
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.
Measured: baseline, week 6,11 and 18
Self-assessment
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).
Measured: Every day in week 1-11
Creatine Kinase
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.
Measured: week 1,6,11 and 18
Activity level
Change in activity level from baseline is measure as step/day. Participants is wearing a pedometer for seven days.
Measured: baseline, week 10 and week 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FSHD - Facioscapulohumeral Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grete Andersen, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grete Andersen, MD, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159963
- Sponsor's protocol ID
- H-4-2014-035 (FSH)
- Acronym
- HIT-FSHD
- Status last verified
- Apr 2016
- First submitted
- 4 Jun 2014
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29050397
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training in Patients With Facioscapulohumeral Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT02159963
- Acronym / sponsor ID
- HIT-FSHD / H-4-2014-035 (FSH)
- Keywords
- FSHD, HIT, Training, Exercise, 10-20-30 interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Grete Andersen, MDUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised training | Experimental | Other: Supervised training, Other: Optional training8 weeks of high intensity training three times a week, once supervised. Followed by 8 weeks home based, unsupervised optional training. |
| Unsupervised training | Experimental | Other: Unsupervised training, Other: ControlParticipants have 8 weeks of non-intervention "Control" period, followed by 8 weeks of home based, unsupervised high intensity interval training. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with Facioscapulohumeral muscular dystrophy or
- healthy matched control, matched for age, gender, BMI and activity level.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised training8 weeks high intensity interval training, 3 times a week, one is supervised, two are home based unsupervised. | Other | Supervised training |
| Unsupervised training8 weeks home based high-intensity-interval cycle-training 3 times a week. | Other | Unsupervised training |
| Optional training8 weeks of optional home based, unsupervised training. | Other | Supervised training |
| Control8 weeks of control period. Participants are doing daily living. | Other | Unsupervised training |
Primary outcome
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.
4 secondary outcomes
Physical function
Time frame: baseline, week 6,11 and 18
Self-assessment
Time frame: Every day in week 1-11
Creatine Kinase
Time frame: week 1,6,11 and 18
Activity level
Time frame: baseline, week 10 and week 18.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Derived from this study: PubMed 29050397Andersen 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.
- The Neuromuscular research units web-sideLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised training, Unsupervised training and Optional training in people with FSHD - Facioscapulohumeral Muscular Dystrophy, run by Grete Andersen, MD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental test (time frame: week 1,6,11 and 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02159963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2016.