Congenital DisorderSEACHangeNCT03262168
Supported Exercise Programme for Adults With Congenital Heart Disease
A study testing Exercise Programme in people with Congenital Disorder and Heart Diseases, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Disorder, Heart Diseases
- What is being tested?
- Exercise Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2017to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Golden Jubilee National Hospital
Clydebank, G81 4DY
About this study
Official title: 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.
Read the 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
- Being tested
- Exercise Programme
- Keywords
- Exercise, Physical Activity
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Heart Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgrammeOther
Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks (for each phase)
Attrition rate
Determine the feasibility of introducing a supported exercise programme by assessing attrition rate throughout the study period.
Measured: 12 weeks (for each phase)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 weeks (for each phase)
Body weight
Change in body weight (measured in kg)
Measured: 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
Measured: 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
Measured: 12 weeks (for each phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start2 Jun 2017
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maureen Mason, MSc, Study chair, Golden Jubilee Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262168
- Sponsor's protocol ID
- GoldenJNH
- Acronym
- SEACHange
- Status last verified
- Jul 2019
- First submitted
- 7 Apr 2017
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual data
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Exercise Programme for Adults With Congenital Heart Disease (SEA CHange)
- ClinicalTrials.gov ID
- NCT03262168
- Acronym / sponsor ID
- SEACHange / GoldenJNH
- Conditions
- Congenital Disorder, Heart Diseases
- Keywords
- Exercise, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group One | Other | Other: Exercise ProgrammeSix Minute Walk Test distance <450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email). |
| Study Group Two | Other | Other: Exercise ProgrammeSix Minute Walk Test distance >450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email). |
| Study Group One - phase 2 | Other | Other: Exercise ProgrammeSix Minute Walk Test distance <450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email). |
| Study Group Two - phase 2 | Other | Other: Exercise ProgrammeSix Minute Walk Test distance >450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email). |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgrammeComplete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires. | Other | Study Group One, Study Group One - phase 2, Study Group Two, Study Group Two - phase 2 |
Primary outcome
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.
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.
9 secondary outcomes
Change in six minute walk test (6MWT)
Time frame: 12 weeks (for each phase)
Change in Sniff Nasal Inspiratory Pressure (SNIP)
Time frame: 12 weeks (for each phase)
Change in Grip Strength
Time frame: 12 weeks (for each phase)
Is there an improvement in level of psychological distress
Time frame: 12 weeks (for each phase)
Is there an improvement in level of psychological distress
Time frame: 12 weeks (for each phase)
Body mass Index (BMI)
Time frame: 12 weeks (for each phase)
Body weight
Time frame: 12 weeks (for each phase)
Is there an improvement in bicep strength
Time frame: 12 weeks (for each phase)
Is there an improvement in quadricep strength
Time frame: 12 weeks (for each phase)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No. No plan to share individual data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen Mason, MSc study chair
Golden Jubilee Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Programme in people with Congenital Disorder and Heart Diseases, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance rate (time frame: 12 weeks (for each phase)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.