Clinical Trial: High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

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.

Detailed Summary:
Sponsor: Karen Brorup Heje Pedersen

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Functional test [ Time Frame: Baseline, week 6, week 11, week 18. ]
    Changes from baseline to end of training in muscle strength measured by handhold dynamometry, in 6 minute walk-test and in 5 time sit-to-stand test is secondary outcome.
  • Self-rated muscle fatigue, muscle pain and activity level [ Time Frame: Every day in week 1-11 ]
    Self-rated muscle fatigue, muscle pain (VAS) and activity level is noted every day in diary in the two "run-in" weeks (baseline data) and thereafter every day in the 8 weeks training program. Changes from baseline is a secondary outcome.
  • Serum concentrations of Creatine Kinase (CK) [ Time Frame: Baseline, Week 3,4,5,6,7,8,9,10,11, week 18. ]

    Serum concentrations of Creatine Kinase (CK) as a measurement of muscle damage. Blood samples are taken at every test day wich is the same for patient group 1 and healthy controls.

    In patient group 2 blood samples are taken at baseline, week 6, week 11 and week 18-

  • Activity level [ Time Frame: Baseline, week 10 and week 18. ]
    Activity levels are measured by using a pedometer for a week at baseline, week 10 and week 18. Changes from baseline is a secondary outcome.


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: June 4, 2014
Date Started: June 2014
Date Completion:
Last Updated: June 4, 2014
Last Verified: June 2014