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

July 30, 2019 updated by: Golden Jubilee National Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attendance rate
Time Frame: 12 weeks (for each phase)
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
Time Frame: 12 weeks (for each phase)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in six minute walk test (6MWT)
Time Frame: 12 weeks (for each phase)
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)
Time Frame: 12 weeks (for each phase)
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
Time Frame: 12 weeks (for each phase)
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
Time Frame: 12 weeks (for each phase)
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
Time Frame: 12 weeks (for each phase)
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)
Time Frame: 12 weeks (for each phase)
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
Time Frame: 12 weeks (for each phase)
Change in body weight (measured in kg)
12 weeks (for each phase)
Is there an improvement in bicep strength
Time Frame: 12 weeks (for each phase)
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
Time Frame: 12 weeks (for each phase)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Golden Jubilee National Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Maureen Mason, MSc, Golden Jubilee Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Clinical Trials on Exercise Programme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings