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Exercise Therapy for Patients With Muscle Dystrophies

Primary Purpose

Muscular Dystrophies

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
Universitat Pompeu Fabra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophies focused on measuring exercise therapy, muscle strength, exercise tolerance, muscular dystrophies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinic de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Training

Control group

Arm Description

This group will engage in a 12-week exercise training program

Usual care. Patients in this group will be offered the same program at the end of the study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Short Physical Performance Battery
Score in this test is derived from three assessments: balance, gait speed and lower limb muscle performance
Upper Body Muscle Strength
Muscle strength of the biceps brachii will be assessed with a hand-held dynamometer
Lower Body Muscle Strength
Muscle strength of the quadriceps will be assessed with a hand-held dynamometer
Handgrip Strength
Handgrip strength will be assessed with a hydraulic dynamometer.
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.
Body Weight
Body weight (kg)
Body Mass Index
Body weight and height will be combined to report the results on body mass index (kg/m2)
Percentage of fat-free mass
Percentage of fat-free mass will be obtained through bio-impedance analysis
Percentage of fat mass
Percentage of fat mass will be obtained through bio-impedance analysis
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.
Respiratory Muscle Strength
Maximal Inspiratory and Expiratory Muscle Strength will be measured according to international guidelines (ATS/ERS) with a MicroRPM.
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

Full Information

First Posted
September 22, 2021
Last Updated
July 27, 2023
Sponsor
Universitat Pompeu Fabra
Collaborators
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05081791
Brief Title
Exercise Therapy for Patients With Muscle Dystrophies
Official Title
Effects of Exercise Therapy on Functional Capacity, Muscle Strength and Patient-reported Outcomes in Patients With Muscle Dystrophies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Pompeu Fabra
Collaborators
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies
Keywords
exercise therapy, muscle strength, exercise tolerance, muscular dystrophies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Post-training assessments will be conducted by a blinded assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training
Arm Type
Experimental
Arm Description
This group will engage in a 12-week exercise training program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care. Patients in this group will be offered the same program at the end of the study
Intervention Type
Behavioral
Intervention Name(s)
Exercise Training
Intervention Description
12-week exercise training program including a combination of endurance and resistance training for 45 minutes, twice a week.
Primary Outcome Measure Information:
Title
Timed Up and Go
Description
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
Time Frame
1 week post-intervention
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery
Description
Score in this test is derived from three assessments: balance, gait speed and lower limb muscle performance
Time Frame
1 week post-intervention
Title
Upper Body Muscle Strength
Description
Muscle strength of the biceps brachii will be assessed with a hand-held dynamometer
Time Frame
1 week post-intervention
Title
Lower Body Muscle Strength
Description
Muscle strength of the quadriceps will be assessed with a hand-held dynamometer
Time Frame
1 week post-intervention
Title
Handgrip Strength
Description
Handgrip strength will be assessed with a hydraulic dynamometer.
Time Frame
1 week post-intervention
Title
Health-Related Quality of Life
Description
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.
Time Frame
1 week post-intervention
Title
Body Weight
Description
Body weight (kg)
Time Frame
1 week post-intervention
Title
Body Mass Index
Description
Body weight and height will be combined to report the results on body mass index (kg/m2)
Time Frame
1 week post-intervention
Title
Percentage of fat-free mass
Description
Percentage of fat-free mass will be obtained through bio-impedance analysis
Time Frame
1 week post-intervention
Title
Percentage of fat mass
Description
Percentage of fat mass will be obtained through bio-impedance analysis
Time Frame
1 week post-intervention
Title
Fatigue
Description
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.
Time Frame
1 week post-intervention
Title
Respiratory Muscle Strength
Description
Maximal Inspiratory and Expiratory Muscle Strength will be measured according to international guidelines (ATS/ERS) with a MicroRPM.
Time Frame
1 week post-intervention
Title
Physical Activity Levels
Description
Accelerometry-assessment of physical activity will be measured in terms of steps per day and minutes spent in light, moderate and vigorous physical activity
Time Frame
1 week post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel Sebio, PhD
Phone
+34679336288
Email
sebio@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Laxe, PhD
Email
laxe@clinic.cat
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Sebio, PhD
Phone
+34634787194

12. IPD Sharing Statement

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Exercise Therapy for Patients With Muscle Dystrophies

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