High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

Not Applicable

Completed

• Conditions: Spinal and Bulbar Muscular Atrophy; Healthy Subjects
• Interventions: Other: Supervised high intensity training; Other: Control period; Other: Unsupervised High intensity training; Other: Optional training

• Registration Number: NCT02156141
• Lead Sponsor: Karen Brorup Heje Pedersen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-05
• Primary Completion: 2016-06
• Study Completion: 2016-06-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unsupervised High intensity training	Unsupervised High intensity training	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.
Supervised high intensity training	Optional training	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.
Supervised high intensity training	Supervised high intensity training	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.
Unsupervised High intensity training	Control period	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Neuromuscular Research Unit; 🇩🇰 Copenhagen, Denmark