The aim of this study is to assess the effects of a small-group community based physical exercise programme on functional exercise capacity, activity rate and health-related quality of life in patients with chronic heart failure (CHF) and chronic…
ID
Source
Brief title
Condition
- Heart failures
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is exercise capacity measured with the 6 Minutes
Walking Test, and daily activity rate, measured by pedometer.
Secondary outcome
Secondary outcomes are: health-related quality of life (disease specific:
Clinical COPD Questionnaire, Minnesota Living with Heart Failure Questionnaire,
and generic: Euroqol 5D, SF-36), health-related behaviour (European Heart
Failure Self-care Behaviour Scale) and self-efficacy (COPD Self-efficacy
scale), and exercise capacity measured with the Incremental Shuttle Walk Test.
Background summary
Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD)
are important causes of morbidity and mortality. The prevalence and incidence
of COPD as well as CHF are still rising. CHF is an important co-morbidity in
COPD and vice versa . It is estimated that approximately one quarter of primary
care patients with COPD also has CHF.
Beneficial effects of exercise based rehabilitation programmes on exercise
capacity have already been demonstrated in patients with solely COPD or solely
CHF. However, no studies are known investigating these effects in patients with
both
Study objective
The aim of this study is to assess the effects of a small-group community based
physical exercise programme on functional exercise capacity, activity rate and
health-related quality of life in patients with chronic heart failure (CHF) and
chronic obstructive pulmonary disease (COPD).
Study design
The CHEST-study is a multicenter randomised controlled trial in patients with
both COPD and CHF, with a 12-month follow-up. Patients will be randomly
assigned to an intervention and a control group. Patients in the intervention
group will participate in a 6-month community based physical exercise
programme, preceded by participation in four self-management sessions. Patients
in the control group will also participate in four self-management sessions,
additional to usual care. Measurements will be performed at baseline, and
directly, a half year and one year after completion of the physical exercise
programme.
Intervention
Patients in the intervention group will participate in a community-based
physical exercies programme. In this programme, patients will exercise in small
groups under supervision of a community based physiotherapist. The intervention
lasts 6 months and is divided into two periods. In the first period, lasting 4
months, the patients will exercise twice a week in the physiotherapy practice,
and once a week at home. The goal of this phase of the program is to achieve an
optimal improvement of exercise capacity and muscle strength. During the second
period, lasting 2 months, patients will exercise once a week in the
physiotherapy practice and once a week at home. The goal of this phase is to
maintain training effects and to make the shift from training under supervision
of a physiotherapist to training at home.
All patients will participate in 4 small group self-management sessions which
will be given by a respiratory nurse and a heart failure nurse. Also, a
physiotherapist and a dietician will contribute to the programme. Patients will
be encouraged to come to the sessions with his or her partner or another person
that is close to him or her. The sessions will be planned prior to the
reactivation programme.
Study burden and risks
The risk for adverse events in this study is negligible. Earlier studies showed
that physical exercise in patients with COPD or CHF is safe and effective.
Also, the pilot-study COPEIII (P08-43) and the COPE-II study were conducted
without occurrence of any adverse events. Medical treatment of the patients in
this study is no other than in regular care, thus no adverse advents are
expected.
Postbus 50000
7500 KA Enschede
NL
Postbus 50000
7500 KA Enschede
NL
Listed location countries
Age
Inclusion criteria
- Age between 40 and 75 years
- A clinical diagnosis of COPD defined by the GOLD-criteria stage 2 and 3
- A diagnosis of chronic heart failure defined by NYHA class II-III
- A left ventricular ejection fraction (LVEF) < 40% measured by
echocardiogram
- A history of smoking of at least 10 pack-years
Exclusion criteria
- Serious other diseases with a survival rate of less than 1 year
- Other diseases which generate symptoms of dyspnoea and/or decreased
exercise capacity, or which seriously influence the ability to walk
- Participation in a pulmonary or cardiac rehabilitation programme less than
1 year ago
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28404.044.09 |