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Completed

NCT Number: NCT02156141

High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

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.

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Key information

Conditions

Spinal and Bulbar Muscular Atrophy Behavior Bulbo-Spinal Atrophy, X-Linked Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Healthy Subjects Heredodegenerative Disorders, Nervous System Motor Activity Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Neuromuscular Research Unit

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised high intensity training

Other

8 weeks of supervised training

Optional training

Other

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

Other

8 weeks with no training.

Unsupervised High intensity training

Other

8 weeks of unsupervised high intensity training.

Primary outcomes

  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 outcomes

  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 outcomes

  1. Serum IGF-1

    Time frame: Baseline, week 11, week 18.

    Changes in serum IGF-1 from baseline to week 11 and 18.

Sponsors and collaborators

Lead sponsor

Karen Brorup Heje Pedersen

Other

Registry information

Acronym: HIT in Kennedy

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 5, 2014
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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