Muscular DystrophiesNCT05081791
Exercise Therapy for Patients with Muscle Dystrophies
A study testing Exercise Training in people with Muscular Dystrophies, run by Universitat Pompeu Fabra at 1 site in Spain.
Trial summary
Muscular Dystrophies (MD) are a heterogeneous group of diseases characterised by muscle wasting that lead to progressive loss of function. Although exercise training has been traditionally neglected to these patients due to concerns regarding muscle damage, research has shown that exercise therapy is safe and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscular Dystrophies
- What is being tested?
- Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 12 Sep 2022to 4 Nov 2024
- 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
- Clinical or Genetically diagnosis of Muscular Dystrophy including Limb-Girdle type I and type II, Myotonic Dystrophy type I and type II and facioscapulohumeral dystrophy.
- Age > 18 years old
- Ability to walk independently for 10 or more metres
Who cannot join
- Inability to understand or read Spanish/Catalan.
- Patients engaging in a similar exercise-based program in the past 12 months
- Patients with severe cognitive, neurological or musculoskeletal impairment unable to participate in the exercise program
- Unstable respiratory, cardiovascular or metabolic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exercise Therapy on Functional Capacity, Muscle Strength and Patient-reported Outcomes in Patients with Muscle Dystrophies
Muscular Dystrophies (MD) are a heterogeneous group of diseases characterised by muscle wasting that lead to progressive loss of function. Although exercise training has been traditionally neglected to these patients due to concerns regarding muscle damage, research has shown that exercise therapy is safe and tolerable in this population and can lead to potential gains in endurance and muscle strength, as well as other patient-reported outcomes such as health-related quality of life.Therefore, in this study, the investigators aim to examine the feasibility, tolerability and safety as well as the effects of a 12-week, exercise-training program in patients with MD on functional capacity, muscle strength, and health-related quality of life.
- Conditions
- Muscular Dystrophies
- Being tested
- Exercise Training
- Keywords
- exercise therapy, muscle strength, exercise tolerance, muscular dystrophies
- Medical subject headings
- Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
12-week exercise training program including a combination of endurance and resistance training for 45 minutes, twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | This group will engage in a 12-week exercise training program Receives: Behavioral: Exercise Training |
| Control group | No intervention | Usual care. Patients in this group will be offered the same program at the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go
Time consumed by the patient to raise from a chair, walk 3 meters, turn 180º, walk 3 metres back and sit down on the chair
Measured: 1 week post-intervention
Secondary outcomes (12)
Short Physical Performance Battery
Score in this test is derived from three assessments: balance, gait speed and lower limb muscle performance
Measured: 1 week post-intervention
Upper Body Muscle Strength
Muscle strength of the biceps brachii will be assessed with a hand-held dynamometer
Measured: 1 week post-intervention
Lower Body Muscle Strength
Muscle strength of the quadriceps will be assessed with a hand-held dynamometer
Measured: 1 week post-intervention
Handgrip Strength
Handgrip strength will be assessed with a hydraulic dynamometer.
Measured: 1 week post-intervention
Health-Related Quality of Life
HRQoL will be measured with the Short-Form Health Survey (SF-12). The score of the scale goes from 0 - 100, with higher scores representing better health-related quality of life.
Measured: 1 week post-intervention
Body Weight
Body weight (kg)
Measured: 1 week post-intervention
Body Mass Index
Body weight and height will be combined to report the results on body mass index (kg/m2)
Measured: 1 week post-intervention
Percentage of fat-free mass
Percentage of fat-free mass will be obtained through bio-impedance analysis
Measured: 1 week post-intervention
Percentage of fat mass
Percentage of fat mass will be obtained through bio-impedance analysis
Measured: 1 week post-intervention
Fatigue
Fatigue will be quantified with the Brief Fatigue Inventory. The scale has 9 items with a maximal score of 10 points. Higher scores represent heavier fatigue.
Measured: 1 week post-intervention
Respiratory Muscle Strength
Maximal Inspiratory and Expiratory Muscle Strength will be measured according to international guidelines (ATS/ERS) with a MicroRPM.
Measured: 1 week post-intervention
Physical Activity Levels
Accelerometry-assessment of physical activity will be measured in terms of steps per day and minutes spent in light, moderate and vigorous physical activity
Measured: 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start12 Sep 2022
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DystrophiesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Raquel Sebio, Universitat Pompeu Fabra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081791
- Sponsor's protocol ID
- HCLINIC - MD - 2021
- Status last verified
- Dec 2024
- First submitted
- 22 Sep 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Therapy on Functional Capacity, Muscle Strength and Patient-reported Outcomes in Patients with Muscle Dystrophies
- ClinicalTrials.gov ID
- NCT05081791
- Acronym / sponsor ID
- HCLINIC - MD - 2021
- Conditions
- Muscular Dystrophies
- Keywords
- exercise therapy, muscle strength, exercise tolerance, muscular dystrophies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 18 Oct 2021 (actual)
- 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.
Muscular Dystrophies (MD) are a heterogeneous group of diseases characterised by muscle wasting that lead to progressive loss of function. Although exercise training has been traditionally neglected to these patients due to concerns regarding muscle damage, research has shown that exercise therapy is safe and tolerable in this population and can lead to potential gains in endurance and muscle strength, as well as other patient-reported outcomes such as health-related quality of life.Therefore, in this study, the investigators aim to examine the feasibility, tolerability and safety as well as the effects of a 12-week, exercise-training program in patients with MD on functional capacity, muscle strength, and health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Behavioral: Exercise TrainingThis group will engage in a 12-week exercise training program |
| Control group | No intervention | –Usual care. Patients in this group will be offered the same program at the end of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical or Genetically diagnosis of Muscular Dystrophy including Limb-Girdle type I and type II, Myotonic Dystrophy type I and type II and facioscapulohumeral dystrophy.
- Age > 18 years old
- Ability to walk independently for 10 or more metres
Key exclusion criteria (4 listed)
- Inability to understand or read Spanish/Catalan.
- Patients engaging in a similar exercise-based program in the past 12 months
- Patients with severe cognitive, neurological or musculoskeletal impairment unable to participate in the exercise program
- Unstable respiratory, cardiovascular or metabolic disease
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 |
|---|---|---|
| Exercise Training12-week exercise training program including a combination of endurance and resistance training for 45 minutes, twice a week. | Behavioural | Exercise Training |
Primary outcome
Timed Up and Go
Time frame: 1 week post-intervention
Time consumed by the patient to raise from a chair, walk 3 meters, turn 180º, walk 3 metres back and sit down on the chair
12 secondary outcomes
Short Physical Performance Battery
Time frame: 1 week post-intervention
Upper Body Muscle Strength
Time frame: 1 week post-intervention
Lower Body Muscle Strength
Time frame: 1 week post-intervention
Handgrip Strength
Time frame: 1 week post-intervention
Health-Related Quality of Life
Time frame: 1 week post-intervention
Body Weight
Time frame: 1 week post-intervention
Body Mass Index
Time frame: 1 week post-intervention
Percentage of fat-free mass
Time frame: 1 week post-intervention
Percentage of fat mass
Time frame: 1 week post-intervention
Fatigue
Time frame: 1 week post-intervention
Respiratory Muscle Strength
Time frame: 1 week post-intervention
Physical Activity Levels
Time frame: 1 week post-intervention
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 6 Dec 2024.
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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 Exercise Training in people with Muscular Dystrophies, run by Universitat Pompeu Fabra at 1 site in Spain.
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 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 6 Dec 2024. 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 Spain. 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?
Timed Up and Go (time frame: 1 week post-intervention). 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 6 Dec 2024.