NCT01671566

Brief Summary

Adults with congenital heart disease have various degrees of impaired exercise capacity compared to healthy controls. Impaired exercise capacity makes everyday activities more difficult and demanding. There are few studies on effect of exercise training in adults with congenital heart disease. The hypothesis of this study is that structured home based exercise training will improve exercise capacity and health status in the studied population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

3.5 years

First QC Date

August 20, 2012

Last Update Submit

March 3, 2016

Conditions

Congenital Heart Defects

Keywords

Congenital Heart defectExercise and Physical fitnessRehabilitationQuality of lifeBehaviour

Outcome Measures

Primary Outcomes (2)

  • Peak VO2 (ml/kg/min)

    Comparison within and between groups

    Before homebased interval exrecise regime and after completion (12 weeks)

  • Endurance time

    at CPET-incremental and constant work rate test at 75% of peak work rate (Watt). Comparison between and within groups.

    Before homebased interval exercise regimen and at completion (12 weeks)

Secondary Outcomes (12)

  • Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).

    Before homebased interval exercise regime and at completion (12 weeks)

  • Adverse events

    Once a week during homebased exercise regime

  • Quality of life

    Before homebased interval exercise regime and at completion (12 weeks)

  • Physical activity level

    Before homebased interval exercise regime and after completion (12 weeks)

  • Exercise self-efficacy

    Before homebased interval exercise regime and after completion

  • +7 more secondary outcomes

Study Arms (2)

Home based interval training

EXPERIMENTAL

12 weeks home based interval training

Behavioral: Home based interval training

Control group

NO INTERVENTION

No structured exercise training.

Interventions

Home based interval trainingBEHAVIORAL

The participant in the intervention group will receive an individualized interval training program. The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt). The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks. During exercise they will wear a heart rate monitoring watch. The registered heart rate will be transferred to a webpage after the exercise session. Only the physiotherapist and participant have the access to this page. The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load. Progression in training load and time will be made when necessary to keep a relevant intensity.

Home based interval training

Eligibility Criteria

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

You may qualify if:

  • Complex congenital heart disease (e.g.; Tetralogy of Fallot, Transpositions of the great arteries, Ebstein, Eisenmenger, Pulmonary atresia or Tricuspid atresia)
  • Clinically stable without significant change the last 3 months
  • Adult (\>18 years)
  • Informed consent

You may not qualify if:

  • Signs of arrhythmia on exercise ECG or relevant clinical arrhythmia
  • Mental retardation or psychiatric illness affecting the ability of independent decisions
  • Other comorbidity affecting physical activity
  • Other circumstances making participation unsuitable
  • Present strategy of regularly executing physical exercise \> 2 times/week in purpose to increase cardiovascular capacity.
  • VO2 peak \> 30 ml/kg/min
  • No access to internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska University hospital

Gothenburg, Gothenburg, SE- 413 45, Sweden

Location

University Hospital

Umeå, Umeå, 90185, Sweden

Location

MeSH Terms

Conditions

Heart Defects, CongenitalMotor ActivityBehavior

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Bengt Johansson, MD, Phd

    Umea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 23, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations

SE(2)