NCT02159963

Brief Summary

The investigators aim to investigate the effect of high-intensity training in patients with facioscapulohumeral muscular dystrophy. Can patients benefit from this type of exercise without muscle damage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

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
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

June 4, 2014

Last Update Submit

April 22, 2016

Conditions

FSHD - Facioscapulohumeral Muscular Dystrophy

Keywords

FSHDHITTrainingExercise10-20-30 interval training

Outcome Measures

Primary Outcomes (1)

  • Incremental test

    An incremental test is performed at baseline (week 1), after 4 weeks interval training, in the end of 8 weeks interval training, and after another 8 week of individual home based training. The primary outcome is change from baseline in maximal oxygen consumption and work load.

    week 1,6,11 and 18

Secondary Outcomes (4)

  • Physical function

    baseline, week 6,11 and 18

  • Self-assessment

    Every day in week 1-11

  • Creatine Kinase

    week 1,6,11 and 18

  • Activity level

    baseline, week 10 and week 18.

Study Arms (2)

Supervised training

EXPERIMENTAL

8 weeks of high intensity training three times a week, once supervised. Followed by 8 weeks home based, unsupervised optional training.

Other: Supervised trainingOther: Optional training

Unsupervised training

EXPERIMENTAL

Participants have 8 weeks of non-intervention "Control" period, followed by 8 weeks of home based, unsupervised high intensity interval training.

Other: Unsupervised trainingOther: Control

Interventions

Supervised trainingOTHER

8 weeks high intensity interval training, 3 times a week, one is supervised, two are home based unsupervised.

Supervised training
Unsupervised trainingOTHER

8 weeks home based high-intensity-interval cycle-training 3 times a week.

Unsupervised training
Optional trainingOTHER

8 weeks of optional home based, unsupervised training.

Supervised training
ControlOTHER

8 weeks of control period. Participants are doing daily living.

Unsupervised training

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Facioscapulohumeral muscular dystrophy or
  • healthy matched control, matched for age, gender, BMI and activity level.

You may not qualify if:

  • Pregnant or breastfeeding women.
  • Physical or mental condition, which could influence the results.
  • Participating in other studies, which could influence the results.
  • Physical or mental condition, which prevent participating in the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Neuromuscular Center, department of Neurology, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Related Publications (1)

  • Andersen G, Hedermann G, Witting N, Duno M, Andersen H, Vissing J. The antimyotonic effect of lamotrigine in non-dystrophic myotonias: a double-blind randomized study. Brain. 2017 Sep 1;140(9):2295-2305. doi: 10.1093/brain/awx192.

    PMID: 29050397DERIVED

Related Links

MeSH Terms

Conditions

Muscular Dystrophy, FacioscapulohumeralMotor Activity

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic 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
MD

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 10, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

DK(1)