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High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy (HIT in Kennedy)

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ClinicalTrials.gov Identifier: NCT02156141
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Karen Brorup Heje Pedersen, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE June 4, 2014
First Posted Date  ICMJE June 5, 2014
Last Update Posted Date February 5, 2018
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
Incremental test [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02156141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
  • Functional test [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 4, 2014)
Serum IGF-1 [ Time Frame: Baseline, week 11, week 18. ]
Changes in serum IGF-1 from baseline to week 11 and 18.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
Official Title  ICMJE High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Spinal and Bulbar Muscular Atrophy
  • Healthy Subjects
Intervention  ICMJE
  • Other: Supervised high intensity training
    8 weeks of supervised training
  • Other: 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.
  • Other: Control period
    8 weeks with no training.
  • Other: Unsupervised High intensity training
    8 weeks of unsupervised high intensity training.
Study Arms  ICMJE
  • Experimental: 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.

    Interventions:
    • Other: Supervised high intensity training
    • Other: Optional training
  • Experimental: 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.

    Interventions:
    • Other: Control period
    • Other: Unsupervised High intensity training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2014)
30
Actual Study Completion Date  ICMJE June 1, 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02156141
Other Study ID Numbers  ICMJE H-4-2014-035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karen Brorup Heje Pedersen, Rigshospitalet, Denmark
Study Sponsor  ICMJE Karen Brorup Heje Pedersen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP