Spinal and Bulbar Muscular Atrophy, Healthy Subjects
Conditions
Keywords
Kennedy's disease, Spinal and bulbar muscular atrophy, High Intensity Training, High Intensity Interval Training, HIT, HIIT, Training, Exercise, 10-20-30
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.
Interventions
OTHERSupervised high intensity training
8 weeks of supervised training
OTHEROptional 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.
OTHERControl period
8 weeks with no training.
OTHERUnsupervised High intensity training
8 weeks of unsupervised high intensity training.
Sponsors
Karen Brorup Heje Pedersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental test | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional test | 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 | 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) | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum IGF-1 | Baseline, week 11, week 18. | Changes in serum IGF-1 from baseline to week 11 and 18. |
Countries
Denmark
Outcome results
None listed