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Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study (FSHD)

Primary Purpose

Facioscapulohumeral Muscle Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Regular exercise
Protein-carbohydrate supplementation
Sponsored by
Grete Andersen, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Facioscapulohumeral Muscle Dystrophy focused on measuring FSHD, Endurance exercise, Protein supplementation, Placebo RCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Verified FSHD
  • Age 18-65
  • Untrained. Less than two hours cardio-training each week the last 4 month.

Exclusion Criteria:

  • Competitive disorders
  • Pregnant and breastfeeding
  • Unable to walk 200 m within 6 min.

Sites / Locations

  • Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Protein supplementation

Placebo supplement

Control

Arm Description

Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water.

Patients consume a drink after each exercise session. The drink consist of flavors mixed in water.

Patients will be tested before and after a none-intervention period of 12 weeks.

Outcomes

Primary Outcome Measures

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.
6MWT
6 min walk test. Outcome in meter.

Secondary Outcome Measures

Risk of falls
Measuring of: Muscle strength, balance, 5-times-up-and-down-chair-test, 14-steps-stair-test.
Daily activity level
assessment of daily-activity level by accelerometer daily-activity level questionary SP36 life quality questionary
Blood samples
Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level

Full Information

First Posted
June 7, 2012
Last Updated
June 4, 2014
Sponsor
Grete Andersen, MD
Collaborators
The Augustinus Foundation, Denmark., Aase and Ejnar Danielsens Foundation, The Danish Rheumatism Association, AP Moeller Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01618331
Brief Title
Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study
Acronym
FSHD
Official Title
The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Grete Andersen, MD
Collaborators
The Augustinus Foundation, Denmark., Aase and Ejnar Danielsens Foundation, The Danish Rheumatism Association, AP Moeller Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facioscapulohumeral Muscle Dystrophy
Keywords
FSHD, Endurance exercise, Protein supplementation, Placebo RCT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein supplementation
Arm Type
Active Comparator
Arm Description
Patients consume a drink after each exercise session. The drink consist of whey protein, maltodextrin, and flavors mixed in water.
Arm Title
Placebo supplement
Arm Type
Placebo Comparator
Arm Description
Patients consume a drink after each exercise session. The drink consist of flavors mixed in water.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will be tested before and after a none-intervention period of 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Regular exercise
Intervention Description
Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein-carbohydrate supplementation
Intervention Description
Dosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks.
Primary Outcome Measure Information:
Title
Maximal oxygen consumption test
Description
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.
Time Frame
up to Week 12
Title
6MWT
Description
6 min walk test. Outcome in meter.
Time Frame
up to Week 12
Secondary Outcome Measure Information:
Title
Risk of falls
Description
Measuring of: Muscle strength, balance, 5-times-up-and-down-chair-test, 14-steps-stair-test.
Time Frame
week: 0 and 12
Title
Daily activity level
Description
assessment of daily-activity level by accelerometer daily-activity level questionary SP36 life quality questionary
Time Frame
week: 0 and 12
Title
Blood samples
Description
Creatine Kinase and myoglobin levels (safe parameter) Inflammatory level
Time Frame
week: 0, 4, 7, 10, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Verified FSHD Age 18-65 Untrained. Less than two hours cardio-training each week the last 4 month. Exclusion Criteria: Competitive disorders Pregnant and breastfeeding Unable to walk 200 m within 6 min.
Facility Information:
Facility Name
Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study

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