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

NCT01618331 | Completed

• 1 other identifier: H-1-2011-149
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Facioscapulohumeral Muscle Dystrophy

Keywords

FSHD; Endurance exercise; Protein supplementation; Placebo RCT

Outcome Measures

Primary Outcomes (2)

• 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.

  up to Week 12

• 6MWT

  6 min walk test. Outcome in meter.

  up to Week 12

Secondary Outcomes (3)

• Risk of falls

  week: 0 and 12

• Daily activity level

  week: 0 and 12

• Blood samples

  week: 0, 4, 7, 10, 12

Study Arms (3)

Protein supplementation

ACTIVE COMPARATOR

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

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.

Behavioral: Regular exercise

Control

NO INTERVENTION

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

Interventions

Regular exercise BEHAVIORAL

Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.

Placebo supplement; Protein supplementation

Protein-carbohydrate supplementation DIETARY_SUPPLEMENT

Dosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks.

Protein supplementation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Grete Andersen, MD: lead
• The Augustinus Foundation, Denmark.: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator
• The Danish Rheumatism Association: collaborator
• AP Moeller Foundation: collaborator

Study Sites (1)

Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 13, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 5, 2014

Record last verified: 2014-06

Locations

DK (1)