Supported Exercise Programme for Adults With Congenital Heart Disease (SEACHange)

Supported Exercise Programme for Adults With Congenital Heart Disease (SEA CHange)

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Congenital Disorder
• Intervention / Treatment: Other: Exercise Programme

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Clydebank, United Kingdom, G81 4DY
    • Golden Jubilee National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Group One; Six Minute Walk Test distance <450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).	Other: Exercise Programme; Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.
Other: Study Group Two; Six Minute Walk Test distance >450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).	Other: Exercise Programme; Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.
Other: 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).	Other: Exercise Programme; Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.
Other: 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).	Other: Exercise Programme; Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in six minute walk test (6MWT)	Change in six minute walk test distance (metres) between 0 and 12 weeks. Offers a simple, readily available and cost effective method for objective evaluation of functional exercise capacity during daily activity.	12 weeks (for each phase)
Change in Sniff Nasal Inspiratory Pressure (SNIP)	Change in Sniff Nasal Inspiratory Pressure (SNIP) between 0 and 12 weeks (study group one). Measured in cmH2O and is used to measure inspiratory muscle strength.	12 weeks (for each phase)
Change in Grip Strength	Change in grip strength. This is measured in pounds (lbs) using a myometer. It is a recognized method of assessing overall nutritional status and health in subjects with medical conditions.	12 weeks (for each phase)
Is there an improvement in level of psychological distress	Change in level of depression (measured using PHQ- 9 questionnaire). It is a reliable and validated self report questionnaire used to help clinicians screen for depression disorder.	12 weeks (for each phase)
Is there an improvement in level of psychological distress	Change in level of anxiety (measured using GAD-7 questionnaire). The GAD -7 is a self report questionnaire used to identify probable cases of generalised anxiety disorder. Recognised as a valid and reliable screening tool	12 weeks (for each phase)
Body mass Index (BMI)	Change in body mass index (measured in kg/m2). Weight (kgs) and height (metres) will be combined to report BMI in kg/m2	12 weeks (for each phase)
Body weight	Change in body weight (measured in kg)	12 weeks (for each phase)
Is there an improvement in bicep strength	Change in bicep strength. This is measured in newtons (N) using a non invasive strain guage/myometer	12 weeks (for each phase)
Is there an improvement in quadricep strength	Change in quadricep strength. This is measured in newtons (N) using a non invasive strain guage/myometer	12 weeks (for each phase)

Collaborators and Investigators

• Sponsor: Golden Jubilee National Hospital
• Investigators: Study Chair: Maureen Mason, MSc, Golden Jubilee Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): December 21, 2018

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: GoldenJNH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No