Facioscapulohumeral Muscle DystrophyFSHDNCT01618331
Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study
A study testing Regular exercise and Protein-carbohydrate supplementation in people with Facioscapulohumeral Muscle Dystrophy, run by Grete Andersen, MD at 1 site in Denmark.
Trial summary
The hypotheses is that regular post exercise supplementation increase fitness and daily activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy. All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and 6MWT is used as primarily effect goals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Facioscapulohumeral Muscle Dystrophy
- What is being tested?
- Regular exercise and Protein-carbohydrate supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Oct 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified FSHD
- Age 18-65
- Untrained. Less than two hours cardio-training each week the last 4 month.
Who cannot join
- Competitive disorders
- Pregnant and breastfeeding
- Unable to walk 200 m within 6 min.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
Copenhagen, 2100
About this study
Official title: The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT Study
The hypotheses is that regular post exercise supplementation increase fitness and daily activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy.
All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and 6MWT is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level.
Read the detailed description
The purpose of this study is to investigate the response to protein-carbohydrate supplementation doing regular exercise in patients with FSHD. All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and a functional 6 min walk test(6MWT) is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level. We measure manuel muscle strength, a balance test, a 5-time-up-and-down-chair-test, a 14 steps-stair-test, accelerometer measuring, daily activity level questionnaire and SP36.
We use a blinded randomized controlled trail. The interventions are 12 weeks regular exercise and consumption of a post-exercise drink. The exercise consists of 30 session of 30 minutes moderate exercise on a cycle-ergometer. After each exercise session patients consume a protein or a non-caloric placebo drink.
- Conditions
- Facioscapulohumeral Muscle Dystrophy
- Being tested
- Regular exercise, Protein-carbohydrate supplementation
- Keywords
- FSHD, Endurance exercise, Protein supplementation, Placebo RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular exerciseBehavioural
Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.
Protein-carbohydrate supplementationDietary supplement
Dosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Protein supplementation | Active comparator | Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water. Receives: Behavioral: Regular exercise; Dietary Supplement: Protein-carbohydrate supplementation |
| Placebo supplement | Placebo comparator | Patients consume a drink after each exercise session. The drink consist of flavors mixed in water. Receives: Behavioral: Regular exercise |
| Control | No intervention | Patients will be tested before and after a none-intervention period of 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption test
All participant are tested with a standardized maximal oxygen consumption test. Maximal oxygen uptake pr. minute pr. kg body (VO2max) weight and maximal work load (Wmax) is measured. The effect of intervention is found in different between groups in relative and absolute improvement in VO2max and Wmax.
Measured: up to Week 12
6MWT
6 min walk test. Outcome in meter.
Measured: up to Week 12
Secondary outcomes (3)
Risk of falls
Measuring of: Muscle strength, balance, 5-times-up-and-down-chair-test, 14-steps-stair-test.
Measured: week: 0 and 12
Daily activity level
assessment of daily-activity level by accelerometer daily-activity level questionary SP36 life quality questionary
Measured: week: 0 and 12
Blood samples
Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level
Measured: week: 0, 4, 7, 10, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facioscapulohumeral Muscle 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grete Andersen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- The Augustinus Foundation, Denmark., Aase and Ejnar Danielsens Foundation, The Danish Rheumatism Association, AP Moeller Foundation
- Responsible party
- Sponsor-investigator, Grete Andersen, MD, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618331
- Sponsor's protocol ID
- H-1-2011-149
- Acronym
- FSHD
- Status last verified
- Jun 2014
- First submitted
- 7 Jun 2012
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT Study
- ClinicalTrials.gov ID
- NCT01618331
- Acronym / sponsor ID
- FSHD / H-1-2011-149
- Conditions
- Facioscapulohumeral Muscle Dystrophy
- Keywords
- FSHD, Endurance exercise, Protein supplementation, Placebo RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Grete Andersen, MDUniversity, hospital or other
- Collaborators
- The Augustinus Foundation, Denmark., Aase and Ejnar Danielsens Foundation, The Danish Rheumatism Association, AP Moeller Foundation
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Jun 2012 (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 hypotheses is that regular post exercise supplementation increase fitness and daily activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy.
All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and 6MWT is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level.
Detailed description
The purpose of this study is to investigate the response to protein-carbohydrate supplementation doing regular exercise in patients with FSHD. All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and a functional 6 min walk test(6MWT) is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level. We measure manuel muscle strength, a balance test, a 5-time-up-and-down-chair-test, a 14 steps-stair-test, accelerometer measuring, daily activity level questionnaire and SP36.
We use a blinded randomized controlled trail. The interventions are 12 weeks regular exercise and consumption of a post-exercise drink. The exercise consists of 30 session of 30 minutes moderate exercise on a cycle-ergometer. After each exercise session patients consume a protein or a non-caloric placebo drink.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protein supplementation | Active comparator | Behavioral: Regular exercise, Dietary Supplement: Protein-carbohydrate supplementationPatients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water. |
| Placebo supplement | Placebo comparator | Behavioral: Regular exercisePatients consume a drink after each exercise session. The drink consist of flavors mixed in water. |
| Control | No intervention | –Patients will be tested before and after a none-intervention period of 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Verified FSHD
- Age 18-65
- Untrained. Less than two hours cardio-training each week the last 4 month.
Key exclusion criteria (3 listed)
- Competitive disorders
- Pregnant and breastfeeding
- Unable to walk 200 m within 6 min.
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 |
|---|---|---|
| Regular exerciseDuration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise. | Behavioural | Placebo supplement, Protein supplementation |
| Protein-carbohydrate supplementationDosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks. | Dietary supplement | Protein supplementation |
Primary outcome
Maximal oxygen consumption test
Time frame: up to Week 12
All participant are tested with a standardized maximal oxygen consumption test. Maximal oxygen uptake pr. minute pr. kg body (VO2max) weight and maximal work load (Wmax) is measured. The effect of intervention is found in different between groups in relative and absolute improvement in VO2max and Wmax.
6MWT
Time frame: up to Week 12
6 min walk test. Outcome in meter.
3 secondary outcomes
Risk of falls
Time frame: week: 0 and 12
Daily activity level
Time frame: week: 0 and 12
Blood samples
Time frame: week: 0, 4, 7, 10, 12
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 5 Jun 2014.
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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 Regular exercise and Protein-carbohydrate supplementation in people with Facioscapulohumeral Muscle 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 3 inclusion and 3 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 5 Jun 2014. 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. Some participants in this study may receive a placebo. 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 consumption test (time frame: up to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2014.