Muscular Dystrophy, FacioscapulohumeralFSHD1NCT01116570
Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients
A study testing Physical training in people with Muscular Dystrophy, Facioscapulohumeral, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
It is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD), aerobic training has been reported to be associated to physiological and functional positive effects without alteration in quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscular Dystrophy, Facioscapulohumeral
- What is being tested?
- Physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2010to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- facioscapulohumeral dystrophy
- Being capable of supporting an exercise on ergocycle
- Social Security regimen affiliated
- Consent form signed
Who cannot join
- Severe cardiac or respiratory insufficiency
- Cardiac pacemaker
- Morbid obesity (BMI upper to 35)
- Anti platelet therapy
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Grenoble
Grenoble, 38000
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Exercise and Myopathies. Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients: Functional, Tissue and Quality of Life Benefits.
It is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD), aerobic training has been reported to be associated to physiological and functional positive effects without alteration in quality of life. The review papers from Van der Kooi et al. (2005), Cup et al. (2007) and Féasson et al. (2010) suggest that the combination of endurance and strength training is even more relevant. Only a few controlled and randomized studies have been conducted on this topic. The impact of such training programs on the skeletal muscle regenerative capacities has not been yet addressed. Moreover, due to the fact that training programs are mainly performed on short-term supervised periods, there is a lack of knowledge regarding long-term effects, patient's autonomy and whether or not regular exercise practice can be maintained in patient's daily life. Also, only a few experiments have reported an integrative view of the potential benefits of such programs on functional, biological and quality of life.
Read the detailed description
Our research project aims at establishing a program of physical training that will fulfill the two following conditions: (i) being compatible with the daily professional, social and family activity of the patients so it can be integrated in their life habits and (ii) being intensive enough to induce functional benefits. This experimental work will be based on multi-factorial evaluations, i.e. biological, physiological, functional, and quality of life questionnaires. This work will be based on a collaboration between the Universities of Saint Etienne (L. Féasson), Grenoble (B Wuyam) and Örebro (F Kadi) within the Rhône-Alpes Reference Centre for Rare Neuromuscular Diseases (JC Antoine).
It is accepted that exercise therapy can be recommended for patients with myopathies but long-term training load still has to be determined for each pathology. In the specific context of facioscapulohumeral dystrophy, we aim at associating the scientific evaluation of physical activity benefits and a therapeutic education of patients in order to contribute to recommendations for physicians and physiotherapists. The purpose of this study is to combine an integrated approach with a better understanding of biological process implicated in this physiological treatment strategy.
- Conditions
- Muscular Dystrophy, Facioscapulohumeral
- Being tested
- Physical training, Control
- Keywords
- Muscular Dystrophy, Facioscapulohumeral, Physical training, Exercise
- Medical subject headings
- Muscular Dystrophy, Facioscapulohumeral, Muscular Dystrophies, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingOther
Physical training during 24 weeks
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Physical training | Experimental | The training will consist in 3 sessions of 35 min of training per week at home on an ergocycle. As a result, lower limb muscles will be mainly solicited. These muscles are heterogeneous in terms of deficiency, but this latter is compatible with cycling. The training will be divided in (i) 2 sessions of 30 min aerobic exercises at a constant but moderate (60% of maximal aerobic power, MAP) intensity followed with 5 sets of 10 revolutions at near-maximal intensity and (ii) an interval-training session. This latter session will consist in 5 min warm-up at 40% MAP followed by 5 times 1 min at 80% MAP (recovery = 4 min at 40% MAP) followed by 5 min of active recovery. Over a 2 to 4 weeks initial period, the program will be conducted in the laboratory or at home under the supervision of a coach. Then a systematic supervision of the sessions by the coach will be performed by phone, by using the heart rate recordings and values of Analogic Visual Scale for pain and fatigue. Receives: Other: Physical training |
| control | Other | None intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal oxygen uptake (VO2max)
VO2max is meseasured directly by respiratory gas analysis during maximal exercise test on ergocycle
Measured: Week 24
Secondary outcomes (5)
Questionnaire of quality of life
"short form 36 health survey questionnaire" SF36
Measured: Day 0, Week 6, Week 12, Week 18 and Week 24
Biopsy
biopsy of the vastus lateralis muscle
Measured: Day 0 and Week 24
maximal oxygen uptake (VO2max)
VO2max is meseasured directly by respiratory gas analysis during maximal exercise test on ergocycle
Measured: Week 6, Week 12 and Week 18
Questionnaire of subjective fatigue
Fatigue severity scale (FSS)
Measured: Day 0, Week 6, Week 12, Week 18 and Week 24
nuclear magnetic resonance imaging
In Paris centre, a total body NMR imaging will be done with standard T2- and T1-weighted images.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2015
- Study completionJan 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 Muscular Dystrophy, FacioscapulohumeralStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris, Örebro University, Sweden
- Responsible party
- Sponsor
- Investigators
- Leonard FEASSON, MD-PhD, Principal investigator, CHU de Saint-EtienneFawzi KADI, MD-PhD, Study chair, Orebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116570
- Sponsor's protocol ID
- 1001035
- Other IDs
- 2010-A00288-31, 2009.1087-14263
- Acronym
- FSHD1
- Status last verified
- Mar 2015
- First submitted
- 28 Apr 2010
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Horwath O, Montiel-Rojas D, Ponsot E, Feasson L, Kadi F. Increased muscle satellite cell content and preserved telomere length in response to combined exercise training in patients with FSHD. J Physiol. 2025 Mar;603(5):1057-1069. doi: 10.1113/JP287033. Epub 2025 Feb 1.
PubMed 39891610
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Myopathies. Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients: Functional, Tissue and Quality of Life Benefits.
- ClinicalTrials.gov ID
- NCT01116570
- Acronym / sponsor ID
- FSHD1 / 1001035
- Conditions
- Muscular Dystrophy, Facioscapulohumeral
- Keywords
- Muscular Dystrophy, Facioscapulohumeral, Physical training, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris, Örebro University, Sweden
- Study start
- Oct 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 May 2010 (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.
It is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD), aerobic training has been reported to be associated to physiological and functional positive effects without alteration in quality of life. The review papers from Van der Kooi et al. (2005), Cup et al. (2007) and Féasson et al. (2010) suggest that the combination of endurance and strength training is even more relevant. Only a few controlled and randomized studies have been conducted on this topic. The impact of such training programs on the skeletal muscle regenerative capacities has not been yet addressed. Moreover, due to the fact that training programs are mainly performed on short-term supervised periods, there is a lack of knowledge regarding long-term effects, patient's autonomy and whether or not regular exercise practice can be maintained in patient's daily life. Also, only a few experiments have reported an integrative view of the potential benefits of such programs on functional, biological and quality of life.
Detailed description
Our research project aims at establishing a program of physical training that will fulfill the two following conditions: (i) being compatible with the daily professional, social and family activity of the patients so it can be integrated in their life habits and (ii) being intensive enough to induce functional benefits. This experimental work will be based on multi-factorial evaluations, i.e. biological, physiological, functional, and quality of life questionnaires. This work will be based on a collaboration between the Universities of Saint Etienne (L. Féasson), Grenoble (B Wuyam) and Örebro (F Kadi) within the Rhône-Alpes Reference Centre for Rare Neuromuscular Diseases (JC Antoine).
It is accepted that exercise therapy can be recommended for patients with myopathies but long-term training load still has to be determined for each pathology. In the specific context of facioscapulohumeral dystrophy, we aim at associating the scientific evaluation of physical activity benefits and a therapeutic education of patients in order to contribute to recommendations for physicians and physiotherapists. The purpose of this study is to combine an integrated approach with a better understanding of biological process implicated in this physiological treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical training | Experimental | Other: Physical trainingThe training will consist in 3 sessions of 35 min of training per week at home on an ergocycle. As a result, lower limb muscles will be mainly solicited. These muscles are heterogeneous in terms of deficiency, but this latter is compatible with cycling. The training will be divided in (i) 2 sessions of 30 min aerobic exercises at a constant but moderate (60% of maximal aerobic power, MAP) intensity followed with 5 sets of 10 revolutions at near-maximal intensity and (ii) an interval-training session. This latter session will consist in 5 min warm-up at 40% MAP followed by 5 times 1 min at 80% MAP (recovery = 4 min at 40% MAP) followed by 5 min of active recovery. Over a 2 to 4 weeks initial period, the program will be conducted in the laboratory or at home under the supervision of a coach. Then a systematic supervision of the sessions by the coach will be performed by phone, by using the heart rate recordings and values of Analogic Visual Scale for pain and fatigue. |
| control | Other | Other: ControlNone intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- facioscapulohumeral dystrophy
- Being capable of supporting an exercise on ergocycle
- Social Security regimen affiliated
- Consent form signed
Key exclusion criteria (4 listed)
- Severe cardiac or respiratory insufficiency
- Cardiac pacemaker
- Morbid obesity (BMI upper to 35)
- Anti platelet therapy
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 |
|---|---|---|
| Physical trainingPhysical training during 24 weeks | Other | Physical training |
| ControlNo intervention | Other | control |
Primary outcome
maximal oxygen uptake (VO2max)
Time frame: Week 24
VO2max is meseasured directly by respiratory gas analysis during maximal exercise test on ergocycle
5 secondary outcomes
Questionnaire of quality of life
Time frame: Day 0, Week 6, Week 12, Week 18 and Week 24
Biopsy
Time frame: Day 0 and Week 24
maximal oxygen uptake (VO2max)
Time frame: Week 6, Week 12 and Week 18
Questionnaire of subjective fatigue
Time frame: Day 0, Week 6, Week 12, Week 18 and Week 24
nuclear magnetic resonance imaging
Time frame: Inclusion
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 1 Apr 2015.
- Derived from this study: PubMed 39891610Horwath O, Montiel-Rojas D, Ponsot E, Feasson L, Kadi F. Increased muscle satellite cell content and preserved telomere length in response to combined exercise training in patients with FSHD. J Physiol. 2025 Mar;603(5):1057-1069. doi: 10.1113/JP287033. Epub 2025 Feb 1.
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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.
Leonard FEASSON, MD-PhD principal investigator
CHU de Saint-Etienne
Fawzi KADI, MD-PhD study chair
Orebro University, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Muscular Dystrophy, Facioscapulohumeral, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
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 4 inclusion and 4 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 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
maximal oxygen uptake (VO2max) (time frame: Week 24). 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 NCT01116570, 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 1 Apr 2015.