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Trial registered on ANZCTR


Registration number
ACTRN12610000902099
Ethics application status
Approved
Date submitted
20/10/2010
Date registered
25/10/2010
Date last updated
3/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of a Supervised Hospital Based Exercise Program on Sleep Quality in Recently Discharged Heart Failure Patients
Scientific title
The Effect of a Supervised Hospital Based Exercise Program on Sleep Quality in Recently Discharged Heart Failure Patients
Secondary ID [1] 252947 0
This study has no secondary IDs
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 258405 0
Condition category
Condition code
Cardiovascular 258571 258571 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those randomised to active intervention will receive the same disease management programme as patients in the control group however patients randomised to the intervention arm will also receive a tailored physical activity programme designed and supervised by a physiotherapist and/or clinical exercise physiologist. Participants will be offered twice weekly hospital based supervised group exercise classes of approximately 1 hour duration for 12 weeks, followed by weekly classes for a further 12 weeks for maintenance (i.e. a total of 36 sessions). Classes will consist of a 10 minute warm-up followed by exercises tailored to the participant’s abilities and including a mixture of aerobic, resistance and interval training. Participants will be taught to monitor exercise intensity using Borg’s rating of perceived exertion (RPE) scale aiming for RPE of 9-13 where 9 is considered fairly light and 13 is considered somewhat hard. In view of the anticipated demographics of the participants and to minimise participant burden, formal cardiopulmonary exercise testing will not be undertaken.

Participants will also be provided with specific advice and support for a graded home exercise programme, in order to facilitate the transition to an ongoing home exercise programme. The home programme will be prescribed at week one, and reviewed weekly for the duration of the intervention, to optimise participant safety and confidence. The home programme will include aerobic and resistance exercises using minimal equipment. An exercise goal of a minimum of four sessions per week of thirty minutes duration will be encouraged; however this program will be modified on a case-by-case basis to ensure exercise safety and adherence for individual participants. Participants will be requested to record their exercise on the provided exercise activity sheet. This sheet will be completed weekly and subsequently reviewed by programme staff at each supervised exercise session, providing an opportunity both for motivation and for assessment of adherence.
Intervention code [1] 257475 0
Lifestyle
Comparator / control treatment
Participants randomised to the control arm will receive a comprehensive disease-based management programme (DMP) including 12 sessions (1 per week) of education (1 hour per week) and self-management support including standard exercise advice. After 12 weeks, control participants will receive fortnightly telephone follow-up by heart failure service staff for a further 12 weeks (attention control). The sessions will reinforce the patient’s physiological understanding of CHF through education on diet, medications, energy conservation and psychological aspects of this chronic disease. The programme also includes education and written support for a home exercise programme in accordance with National Heart Foundation (NHF) guidelines. The intensity of the intervention is specifically tailored to the patient.
Control group
Active

Outcomes
Primary outcome [1] 259416 0
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 259416 0
Three months post commencement of study program.
Secondary outcome [1] 266045 0
Depression using the geriatric depression scale (GDS)
Timepoint [1] 266045 0
Three months post commencement of study program.
Secondary outcome [2] 266046 0
Functional capacity as measured using a six minute walk test
Timepoint [2] 266046 0
Three months post commencement of study program.

Eligibility
Key inclusion criteria
1. Acute admission to hospital with symptomatic HF as a dominant clinical diagnosis. Recruitment to occur within 6 weeks of discharge;
2. Evidence during admission of clinically significant criteria including documented symptoms (dyspnoea, fatigue and or peripheral oedema) and signs (raised JVP, displaced apex beat, 3rd heart sound and/or crepitations on chest examination) of HF combined with chest x-ray changes (pulmonary venous congestion, pulmonary oedema, cardiomegaly) or echocardiographic evidence of left ventricular dysfunction;
3. Echocardiography within six months;
4. On medical therapy for HF;
5. Able to regularly attend the duration of the programme and follow-ups;
6. Satisfy safety criteria;
7. Signed written informed consent;
8. Aged 18 years or older.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Terminally ill;
2. Serious cognitive impairment;
3. Serious other physical impairment which prevents attendance and participation;
4. Implantable Cardiac Defibrillator (ICD) insertion within 4 weeks of programme commencement (eligible if 4 to 6 weeks post implant);
5. Cardiac resynchronisation therapy within six months of programme commencement;
6. Awaiting cardiovascular procedure including revascularisation or hospitalisation for surgery;
7. Exercise testing or clinical judgement by exercise specialist that would preclude safe exercise training participation;
8. Completed a full 12 week regime of formal exercise rehabilitation in the past 12 month period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation using computer random number generation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generation in permuted blocks stratified by site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3390 0
4029
Recruitment postcode(s) [2] 3391 0
4032
Recruitment postcode(s) [3] 3392 0
4131

Funding & Sponsors
Funding source category [1] 257841 0
Self funded/Unfunded
Name [1] 257841 0
Address [1] 257841 0
Country [1] 257841 0
Primary sponsor type
Individual
Name
Jessica Suna
Address
Internal Medicine Research Unit
Level 7, Block 7
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 257047 0
None
Name [1] 257047 0
Address [1] 257047 0
Country [1] 257047 0
Other collaborator category [1] 251579 0
Individual
Name [1] 251579 0
Associate Professor Alison Mudge
Address [1] 251579 0
Staff Specialist
Level 6, Clinical Sciences Building
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country [1] 251579 0
Australia
Other collaborator category [2] 251583 0
Individual
Name [2] 251583 0
Dr Adam Scott
Address [2] 251583 0
Cardiac Scientist in Charge
Cardiology
Level 3, Dr James Mayne Building
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country [2] 251583 0
Australia
Other collaborator category [3] 251584 0
Individual
Name [3] 251584 0
Dr Ian Stewart
Address [3] 251584 0
Senior Lecturer
Faculty of Health
School of Human Movement Studies
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Country [3] 251584 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259877 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 259877 0
Level 7, Block 7
Royal Brisbane and Women's Hospital
Herston QLD 4029
Ethics committee country [1] 259877 0
Australia
Date submitted for ethics approval [1] 259877 0
Approval date [1] 259877 0
29/05/2009
Ethics approval number [1] 259877 0
2008/001
Ethics committee name [2] 259919 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [2] 259919 0
Lower Ground Floor
Administration Building
The Prince Charles Hospital
Rode Road
Chermside Qld 4032
Ethics committee country [2] 259919 0
Australia
Date submitted for ethics approval [2] 259919 0
Approval date [2] 259919 0
19/06/2009
Ethics approval number [2] 259919 0
EC2722
Ethics committee name [3] 259920 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [3] 259920 0
Princess Alexandra Hospital
Woolloongabba QLD 4102
Ethics committee country [3] 259920 0
Australia
Date submitted for ethics approval [3] 259920 0
Approval date [3] 259920 0
16/06/2009
Ethics approval number [3] 259920 0
2009/100

Summary
Brief summary
Despite favourable trends in survival, heart failure (HF) remains a leading cause of mortality and morbidity across the developed world. Consequently, emphasis has been placed upon identifying solutions for the treatable co-morbidities associated with this chronic, incurable disease. Sleep disorders are one of the most commonly reported features of HF. Sleep disorders are a group of syndromes which are characterised by disturbance in the amount, quality, timing or architecture of sleep. The most frequent and troubling of these in HF includes Obstructive Sleep Apnoea (OSA) syndrome, Central Sleep Apnoea syndrome (CSA), periodic limb movement disorder and insomnia. These disorders impair quality of life (QOL) and are linked with repeat health care visits. Exercise is an important component of the multidisciplinary management of HF and has recently been established in the ACTION:HF study as an effective means of improving the QOL of HF patients. Exercise is also thought to improve sleep in this population however this theory remains controversial in light of small number of studies conducted in the area to date.

The hypothesis that exercise improves sleep in HF patients has been developed in reflection of the positive effect of exercise on sleep seen in elderly populations and patients with other chronic diseases. These studies are valuable sources of information as the typical HF patient shares many of the co-morbidities seen in patients studied. The common theme established in these publications is that physically active patients have improved sleep duration and quality when compared to their sedentary counterparts. Physical activity has been identified to relieve problems associated with frailty and disease co-morbidities and lacks many of the negative side-affects related to sleep medications such as confusion and falls. It is linked with improvements in vitality, symptom severity, daytime sleepiness, depression, QOL, pain and strength. Physically active patients also exhibit improved ventilatory capacity, reduced vascular resistance and improvements in endothelial dysfunction.

Polysomnography (PSG) is the current gold standard device for the examination of sleep disorders but is expensive, labour intensive and limited in its availability. Reliance on quantitative measures to identify sleep disturbance may not be practical in this population given the limited availability of PSG combined with the fact that HF is an increasingly common disease with correspondingly high rates of sleep disorders. In addition, as it is often the individual’s perception of their sleep state which motivates them to seek treatment, examination of sleep quality may be cost-effective, convenient alternative to ensure the prompt identification of sleep disturbance.

Appropriate medical management of HF is thought to alleviate sleep disturbance however studies suggest that treatments produce only minor improvements in sleep in this population. The most common non-pharmacological form of treatment for diagnosed sleep apnoeas is continuous positive airway pressure (CPAP). Several studies have found that although CPAP may decrease the number of apnoeas and hypopneas and improve sympathetic activity it fails to improve cardiovascular variables or overall survival in HF. CPAP machines are also difficult to use and cause significant patient discomfort.

Given issues associated with current screening and treatment methods of sleep disorders and in light of increasing demand on the health care resources in this population there is a need to identify alternative solutions for sleep problems in HF patients. Exercise presents a potential therapeutic alternative given poor CPAP compliance and limited alternative treatment options. The examination of the effect of exercise on sleep quality in contrast to sleep architecture is important as an outcome of improved sleep is one which carries a real meaning for patients and is likely to improve compliance with exercise regimes. In addition, the improvement of sleep through exercise is expected to have direct physiological benefits for HF patients and may improve cardiovascular variables and overall survival.
Trial website
Trial related presentations / publications
European Society of Cardiology Heart Failure Congress 2012
Public notes

Contacts
Principal investigator
Name 31774 0
Address 31774 0
Country 31774 0
Phone 31774 0
Fax 31774 0
Email 31774 0
Contact person for public queries
Name 15021 0
Jessica Suna
Address 15021 0
Internal Medicine Research Unit
Block 7, Level 7
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 15021 0
Australia
Phone 15021 0
+61 7 3646 6207
Fax 15021 0
+61 7 3646 6943
Email 15021 0
Jessica_Suna@health.qld.gov.au
Contact person for scientific queries
Name 5949 0
Jessica Suna
Address 5949 0
Internal Medicine Research Unit
Block 7, Level 7
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 5949 0
Australia
Phone 5949 0
+61 7 3646 6207
Fax 5949 0
+61 7 3646 6943
Email 5949 0
Jessica_Suna@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary