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Clinical Trials/NCT02156141
NCT02156141
Completed
Not Applicable

High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

Karen Brorup Heje Pedersen1 site in 1 country10 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal and Bulbar Muscular Atrophy
Sponsor
Karen Brorup Heje Pedersen
Enrollment
10
Locations
1
Primary Endpoint
Incremental test
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

We want investigate if high intensity training can increase daily functionality without causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if there is a difference in effect with supervised and unsupervised training. Furthermore we want to study if a supervised training program will motivate participants to continue training by the end of the program.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
June 1, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Karen Brorup Heje Pedersen
Responsible Party
Sponsor Investigator
Principal Investigator

Karen Brorup Heje Pedersen

Bachelor in medicine

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Spinal and bulbar muscular atrophy or
  • Healthy control subjects matched individually with participating patients on age, sex, BMI and activity level.

Exclusion Criteria

  • More than 1 hour of fitness weekly before inclusion
  • Other disease possibly confounding the results
  • Pregnancy or breastfeeding
  • Participations in other scientific studies wich could influence on the results during the last 30 days before inclusion.
  • Physical and/or mental conditions preventing participating in the study protocol.

Outcomes

Primary Outcomes

Incremental test

Time Frame: Baseline, week 6, week 11, week 18

Primary outcome is changes from baseline in maximal oxygen consumption and maximal workload after a 8 week supervised training program followed by a 8 week non-supervised optional training period. during and after 8 weeks of High Intensity Training on a cycle ergometer. The outcome is measured by an incremental test on a cycle ergometer.

Secondary Outcomes

  • Functional test(Baseline, week 6, week 11, week 18.)
  • Self-rated muscle fatigue, muscle pain and activity level(Every day in week 1-11)
  • Serum concentrations of Creatine Kinase (CK)(Baseline, Week 3,4,5,6,7,8,9,10,11, week 18.)
  • Activity level(Baseline, week 10 and week 18.)

Study Sites (1)

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