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Trial record 5 of 14 for:    sbma

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

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.

Condition or disease Intervention/treatment Phase
Spinal and Bulbar Muscular Atrophy Healthy Subjects Other: Supervised high intensity training Other: Optional training Other: Control period Other: Unsupervised High intensity training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
Study Start Date : June 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.

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.

Other: Control period
8 weeks with no training.

Other: Unsupervised High intensity training
8 weeks of unsupervised high intensity training.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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-


  4. 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.


Other Outcome Measures:
  1. Serum IGF-1 [ Time Frame: Baseline, week 11, week 18. ]
    Changes in serum IGF-1 from baseline to week 11 and 18.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156141


Locations
Denmark
Neuromuscular Research Unit
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Karen Brorup Heje Pedersen

Additional Information:
Responsible Party: Karen Brorup Heje Pedersen, Bachelor in medicine, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02156141     History of Changes
Other Study ID Numbers: H-4-2014-035
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Karen Brorup Heje Pedersen, Rigshospitalet, Denmark:
Kennedy's disease
Spinal and bulbar muscular atrophy
High Intensity Training
High Intensity Interval Training
HIT
HIIT
Training
Exercise
10-20-30

Additional relevant MeSH terms:
Atrophy
Muscular Atrophy
Muscular Disorders, Atrophic
Bulbo-Spinal Atrophy, X-Linked
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Muscular Atrophy, Spinal
Spinal Cord Diseases
Central Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Motor Neuron Disease
Genetic Diseases, X-Linked
Genetic Diseases, Inborn