Supported Exercise Programme for Adults With Congenital Heart Disease

NCT03262168 | Completed

• 1 other identifier: GoldenJNH
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate if the introduction of a supported exercise programme can improve physical and psychological well-being for adults with congenital heart disease.

Conditions

Congenital Disorder; Heart Diseases

Keywords

Exercise; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Attendance rate

  Determine the feasibility of introducing a supported exercise programme in to clinical practice. This will be measured through attendance to the programme and interaction with the online resource.

  12 weeks (for each phase)

• Attrition rate

  Determine the feasibility of introducing a supported exercise programme by assessing attrition rate throughout the study period.

  12 weeks (for each phase)

Secondary Outcomes (9)

• Change in six minute walk test (6MWT)

  12 weeks (for each phase)

• Change in Sniff Nasal Inspiratory Pressure (SNIP)

  12 weeks (for each phase)

• Change in Grip Strength

  12 weeks (for each phase)

• Is there an improvement in level of psychological distress

  12 weeks (for each phase)

• Is there an improvement in level of psychological distress

  12 weeks (for each phase)

Study Arms (4)

Study Group One

OTHER

Six Minute Walk Test distance \<450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).

Other: Exercise Programme

Study Group Two

OTHER

Six Minute Walk Test distance \>450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).

Other: Exercise Programme

Study Group One - phase 2

OTHER

Six Minute Walk Test distance \<450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).

Other: Exercise Programme

Study Group Two - phase 2

OTHER

Six Minute Walk Test distance \>450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).

Other: Exercise Programme

Interventions

Exercise Programme OTHER

Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.

Study Group One; Study Group One - phase 2; Study Group Two; Study Group Two - phase 2

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in Scotland
• Diagnosis of congenital heart disease
• Walks less than 450 metres on a 6 minute walk test (Group 1)
• Walks more than 450 metres on a 6 minute walk test (Group 2)

You may not qualify if:

• No access to internet or telephone
• Non English speaking (If the pilot study is successful, we anticipate that materials and programmes could be translated and accessible to non English speakers)
• Vulnerable adults
• Severe aortic stenosis or severe left ventricular outflow tract obstruction (LVOTO)
• Eisenmenger Physiology (ongoing study recruitment with SPVU)
• Currently prescribed Advanced Pulmonary Vasodilator therapy

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, G81 4DY, United Kingdom

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Behavior

Study Officials

• Maureen Mason, MSc

  Golden Jubilee Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants compete a six minute walk test (6MWT). Those who achieve less than 450 metres will be assigned to study group one. Participants who achieve greater than 450 metres on 6MWT will be assigned to study group two.

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: August 25, 2017
• Study Start: June 2, 2017
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)