NCT02156141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

June 4, 2014

Last Update Submit

February 1, 2018

Conditions

Spinal and Bulbar Muscular AtrophyHealthy Subjects

Keywords

Kennedy's diseaseSpinal and bulbar muscular atrophyHigh Intensity TrainingHigh Intensity Interval TrainingHITHIITTrainingExercise10-20-30

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, week 6, week 11, week 18

Secondary Outcomes (4)

  • Functional test

    Baseline, week 6, week 11, week 18.

  • Self-rated muscle fatigue, muscle pain and activity level

    Every day in week 1-11

  • Serum concentrations of Creatine Kinase (CK)

    Baseline, Week 3,4,5,6,7,8,9,10,11, week 18.

  • Activity level

    Baseline, week 10 and week 18.

Other Outcomes (1)

  • Serum IGF-1

    Baseline, week 11, week 18.

Study Arms (2)

Supervised high intensity training

EXPERIMENTAL

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 trainingOther: Optional training

Unsupervised High intensity training

EXPERIMENTAL

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 periodOther: Unsupervised High intensity training

Interventions

Supervised high intensity trainingOTHER

8 weeks of supervised training

Supervised high intensity training
Optional trainingOTHER

8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not.

Supervised high intensity training
Control periodOTHER

8 weeks with no training.

Unsupervised High intensity training
Unsupervised High intensity trainingOTHER

8 weeks of unsupervised high intensity training.

Unsupervised High intensity training

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Spinal and bulbar muscular atrophy or
  • Healthy control subjects matched individually with participating patients on age, sex, BMI and activity level.

You may not qualify if:

  • Other disease possibly confounding the results
  • Pregnancy or breastfeeding
  • Physical and/or mental conditions preventing participating in the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromuscular Research Unit

Copenhagen, 2100, Denmark

Location

Related Links

MeSH Terms

Conditions

Bulbo-Spinal Atrophy, X-LinkedMotor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy, SpinalSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesMotor Neuron DiseaseNeuromuscular DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Bachelor in medicine

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 5, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

DK(1)