Back to resultsHigh Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy (HIT in Kennedy)
Primary Purpose
Spinal and Bulbar Muscular Atrophy, Healthy Subjects
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Supervised high intensity training
Optional training
Control period
Unsupervised High intensity training
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal and Bulbar Muscular Atrophy focused on measuring Kennedy's disease, Spinal and bulbar muscular atrophy, High Intensity Training, High Intensity Interval Training, HIT, HIIT, Training, Exercise, 10-20-30
Eligibility Criteria
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.
Sites / Locations
- Neuromuscular Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Supervised high intensity training
Unsupervised High intensity training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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-
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.
Full Information
NCT ID
NCT02156141
First Posted
June 4, 2014
Last Updated
February 1, 2018
Sponsor
Karen Brorup Heje Pedersen
1. Study Identification
Unique Protocol Identification Number
NCT02156141
Brief Title
High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
Acronym
HIT in Kennedy
Official Title
High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Brorup Heje Pedersen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal and Bulbar Muscular Atrophy, Healthy Subjects
Keywords
Kennedy's disease, Spinal and bulbar muscular atrophy, High Intensity Training, High Intensity Interval Training, HIT, HIIT, Training, Exercise, 10-20-30
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised high intensity training
Arm Type
Experimental
Arm Description
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.
Arm Title
Unsupervised High intensity training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised high intensity training
Intervention Description
8 weeks of supervised training
Intervention Type
Other
Intervention Name(s)
Optional training
Intervention Description
8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not.
Intervention Type
Other
Intervention Name(s)
Control period
Intervention Description
8 weeks with no training.
Intervention Type
Other
Intervention Name(s)
Unsupervised High intensity training
Intervention Description
8 weeks of unsupervised high intensity training.
Primary Outcome Measure Information:
Title
Incremental test
Description
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.
Time Frame
Baseline, week 6, week 11, week 18
Secondary Outcome Measure Information:
Title
Functional test
Description
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.
Time Frame
Baseline, week 6, week 11, week 18.
Title
Self-rated muscle fatigue, muscle pain and activity level
Description
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.
Time Frame
Every day in week 1-11
Title
Serum concentrations of Creatine Kinase (CK)
Description
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-
Time Frame
Baseline, Week 3,4,5,6,7,8,9,10,11, week 18.
Title
Activity level
Description
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.
Time Frame
Baseline, week 10 and week 18.
Other Pre-specified Outcome Measures:
Title
Serum IGF-1
Description
Changes in serum IGF-1 from baseline to week 11 and 18.
Time Frame
Baseline, week 11, week 18.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Neuromuscular Research Unit
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://www.neuromuscular.dk
Description
Website of Neuromuscular Research Unit, Rigshospitalet, Denmark.
Learn more about this trial
High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
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