Exercise Therapy for Patients With Muscle Dystrophies

• Sponsor: Universitat Pompeu Fabra (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05081791
• Collaborator: Hospital Clinic of Barcelona (Other)
• Enrollment: 42
• Arms: 2
• Anticipated Duration (Months): 32

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Muscular Dystrophies	Behavioral: Exercise Training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Post-training assessments will be conducted by a blinded assessor
• Primary Purpose: Treatment
• Official Title: Effects of Exercise Therapy on Functional Capacity, Muscle Strength and Patient-reported Outcomes in Patients With Muscle Dystrophies
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Training This group will engage in a 12-week exercise training program	Behavioral: Exercise Training; 12-week exercise training program including a combination of endurance and resistance training for 45 minutes, twice a week.
No Intervention: Control group Usual care. Patients in this group will be offered the same program at the end of the study

Outcome Measures

Primary Outcome Measures

1. Timed Up and Go [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

Secondary Outcome Measures

1. Short Physical Performance Battery [1 week post-intervention]

   Score in this test is derived from three assessments: balance, gait speed and lower limb muscle performance

2. Upper Body Muscle Strength [1 week post-intervention]

   Muscle strength of the biceps brachii will be assessed with a hand-held dynamometer

3. Lower Body Muscle Strength [1 week post-intervention]

   Muscle strength of the quadriceps will be assessed with a hand-held dynamometer

4. Handgrip Strength [1 week post-intervention]

   Handgrip strength will be assessed with a hydraulic dynamometer.

5. Health-Related Quality of Life [1 week post-intervention]

   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.

6. Body Weight [1 week post-intervention]

   Body weight (kg)

7. Body Mass Index [1 week post-intervention]

   Body weight and height will be combined to report the results on body mass index (kg/m2)

8. Percentage of fat-free mass [1 week post-intervention]

   Percentage of fat-free mass will be obtained through bio-impedance analysis

9. Percentage of fat mass [1 week post-intervention]

   Percentage of fat mass will be obtained through bio-impedance analysis

10. Fatigue [1 week post-intervention]

    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.

11. Respiratory Muscle Strength [1 week post-intervention]

    Maximal Inspiratory and Expiratory Muscle Strength will be measured according to international guidelines (ATS/ERS) with a MicroRPM.

12. Physical Activity Levels [1 week post-intervention]

    Accelerometry-assessment of physical activity will be measured in terms of steps per day and minutes spent in light, moderate and vigorous physical activity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universitat Pompeu Fabra
• Hospital Clinic of Barcelona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raquel Sebio, Lecturer, Universitat Pompeu Fabra
• ClinicalTrials.gov Identifier: NCT05081791
• Other Study ID Numbers: HCLINIC - MD - 2021
• First Posted: Oct 18, 2021
• Last Update Posted: Oct 18, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raquel Sebio, Lecturer, Universitat Pompeu Fabra: exercise therapy; muscle strength; exercise tolerance; muscular dystrophies
• Additional relevant MeSH terms: Muscular Dystrophies

Study Results

No Results Posted as of Oct 18, 2021