High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

Healthy Subjects Clinical Trial

— HIT in Kennedy  

Official title:

High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156141
• Other study ID #: H-4-2014-035
• 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
• 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.

Related Conditions & MeSH terms

• Atrophy
• Bulbo-Spinal Atrophy, X-Linked
• Healthy Subjects
• Muscular Atrophy
• Muscular Disorders, Atrophic
• Spinal and Bulbar Muscular Atrophy

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.

External Links

•   Website of Neuromuscular Research Unit, Rigshospitalet, Denmark.