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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02156141
Other study ID # H-4-2014-035
Secondary ID
Status Completed
Phase N/A
First received June 4, 2014
Last updated February 1, 2018
Start date June 2014
Est. completion date June 1, 2016

Study information

Verified date February 2018
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 1, 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Supervised high intensity training
8 weeks of supervised training
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.
Control period
8 weeks with no training.
Unsupervised High intensity training
8 weeks of unsupervised high intensity training.

Locations

Country Name City State
Denmark Neuromuscular Research Unit Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Karen Brorup Heje Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Serum IGF-1 Changes in serum IGF-1 from baseline to week 11 and 18. Baseline, week 11, week 18.
Primary 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 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.
Secondary 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
Secondary 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.
Secondary 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.
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