High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal and Bulbar Muscular Atrophy, Healthy Subjects

Intervention / Treatment
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* Other: Supervised high intensity training
* Other: Optional training
* Other: Control period
* Other: Unsupervised High intensity training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised high intensity training<br>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<br>* 8 weeks of supervised training<br>Other: Optional training<br>* 8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not.<br>|
| Experimental: Unsupervised High intensity training<br>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<br>* 8 weeks with no training.<br>Other: Unsupervised High intensity training<br>* 8 weeks of unsupervised high intensity training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kennedy's disease, Spinal and bulbar muscular atrophy, High Intensity Training, High Intensity Interval Training, HIT, HIIT, Training, Exercise, 10-20-30