High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy (HIT in Kennedy)
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|ClinicalTrials.gov Identifier: NCT02156141|
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal and Bulbar Muscular Atrophy Healthy Subjects||Other: Supervised high intensity training Other: Optional training Other: Control period Other: Unsupervised High intensity training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 1, 2016|
Experimental: Supervised high intensity training
8 weeks of supervised high intensity training, 10 minutes, 3 times a week (once a week supervised) on a cycle ergometer followed by 8 weeks of unsupervised optional training.
Participants: Patients with Kennedy's disease or healthy control subjects (individually matched with patients).
Participants: Patients with Kennedys disease and healthy control subjects.
Other: Supervised high intensity training
8 weeks of supervised training
Other: Optional training
8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not.
Experimental: Unsupervised High intensity training
8 week control period with no training followed by 8 weeks of unsupervised high intensity training on a cycle ergometer.
Participants: Patients with Kennedy's disease.
Other: Control period
8 weeks with no training.
Other: Unsupervised High intensity training
8 weeks of unsupervised high intensity training.
- 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.
- 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.
- Serum IGF-1 [ Time Frame: Baseline, week 11, week 18. ]Changes in serum IGF-1 from baseline to week 11 and 18.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156141
|Neuromuscular Research Unit|
|Copenhagen, Denmark, 2100|