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The Effect of a Supervised Hospital Based Exercise Program on Sleep Quality in Recently Discharged Heart Failure Patients

The Effect of a Supervised Hospital Based Exercise Program on Sleep Quality in Recently Discharged Heart Failure Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000902099
Enrollment
62
Registered
2010-10-25
Start date
2009-06-11
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 w

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.

Sponsors

Jessica Suna
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026