NCT02158156

Brief Summary

The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks. Participants will be evaluated on maximal oxygen consumption and maximal workload measured by an incremental test at baseline and at the end of the exercise period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

June 4, 2014

Last Update Submit

June 5, 2014

Conditions

Oculopharyngeal Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • Efficacy based on VO2max

    Difference in VO2max measured before and after intervention

    10 weeks

Secondary Outcomes (9)

  • SF-36 Questionaire

    10 weeks

  • 6 minute walk test

    10 weeks

  • Intensity in maximal load (Watt)

    10 weeks

  • Level of plasma creatine kinase

    10 weeks

  • Level of plasma myoglobin

    10 weeks

  • +4 more secondary outcomes

Study Arms (1)

Excercise

EXPERIMENTAL

10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Ten weeks of home-training on a cycle ergometer 3 times a week for 30 minutes.

Excercise

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Danish patients with Oculopharyngeal muscular dystrophy

You may not qualify if:

  • Patients who are too week to train on an cycle-ergometer for 10 weeks
  • Patients with other health issues wich confound the interpretation of the efficacy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromuscular Research Unit

Copenhagen, 2100, Denmark

RECRUITING

Related Links

MeSH Terms

Conditions

Muscular Dystrophy, Oculopharyngeal

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karen BH Pedersen, Bsc.med.

    Neuromuscular Research Unit, Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bsc Medicine

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

DK(1)