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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised high intensity training | Experimental | 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. |
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| Unsupervised High intensity training | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised high intensity training | Other | 8 weeks of supervised training |
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| Measure | Description | Time Frame |
|---|---|---|
| Incremental test | 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. | Baseline, week 6, week 11, week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional test | 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. | Baseline, week 6, week 11, week 18. |
| Self-rated muscle fatigue, muscle pain and activity level |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IGF-1 | Changes in serum IGF-1 from baseline to week 11 and 18. | Baseline, week 11, week 18. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromuscular Research Unit | Copenhagen | 2100 | Denmark |
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| Label | URL |
|---|---|
| Website of Neuromuscular Research Unit, Rigshospitalet, Denmark. | View source |
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| ID | Term |
|---|---|
| D055534 | Bulbo-Spinal Atrophy, X-Linked |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Optional training | Other | 8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not. |
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| Control period | Other | 8 weeks with no training. |
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| Unsupervised High intensity training | Other | 8 weeks of unsupervised high intensity training. |
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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. |
| Every day in week 1-11 |
| Serum concentrations of Creatine Kinase (CK) | 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- | Baseline, Week 3,4,5,6,7,8,9,10,11, week 18. |
| Activity level | 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. | Baseline, week 10 and week 18. |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D016472 | Motor Neuron Disease |
| D009468 | Neuromuscular Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |