Supported Exercise Programme for Adults With Congenital Heart Disease

NCT ID: NCT03262168

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-02
• Study Completion Date: 2018-12-21

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.

Detailed Description

Congenital heart disease (CHD) describes heart defects present from birth. The majority of affected patients will require lifelong care to not only manage their medical condition, but also to offer support and guidance on living with their specific heart condition. Exercise and physical activity is one such area where patients often require support and advice. Recommendations are in place for health care providers to promote physical activity for this patient population. However, many health care providers find it difficult to know what level of exercise is reasonable or how to escalate current exercise programmes.

The benefits of regular exercise are well known and evidence suggests that even a modest increase in physical activity can reduce morbidity, improve psychological wellbeing and protect against cardiovascular disease.

This pilot study will determine the feasibility of introducing a supported exercise programme to clinical practice. The investigators aim to assess if improvements can be made in both physical and psychological well-being for adults with CHD who are living in Scotland. After initial assessment and baseline measurements are obtained, participants will follow a twelve week individualised programme. The investigators will keep in regular contact with the participant throughout and arrange interval and final assessments. The baseline measurements will be repeated during the final assessment at 12 weeks. Investigators anticipate that the study will also help to establish a programme that will help to improve the way adults who were born with a heart condition can be supported with physical activity on a long term basis.

Conditions

Congenital Disorder; Heart Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study Group One

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

Group Type: OTHER

Exercise Programme

Intervention Type: OTHER

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

Study Group Two

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

Group Type: OTHER

Exercise Programme

Intervention Type: 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 - phase 2

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

Group Type: OTHER

Exercise Programme

Intervention Type: OTHER

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

Study Group Two - phase 2

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

Group Type: OTHER

Exercise Programme

Intervention Type: OTHER

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

Interventions

Exercise Programme

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maureen Mason, MSc

Role: STUDY_CHAIR

Golden Jubilee Research Institute

Locations

Golden Jubilee National Hospital

Clydebank, , United Kingdom

Countries

United Kingdom

Other Identifiers

GoldenJNH

Identifier Type: -

Identifier Source: org_study_id