The main objective of this observational study is to examine DPA in HF patients (NYHA II and III) by means of accelerometry. The secondary objective is to assess the influence of a number of psychosocial determinants (e.g. self-efficacy, intrinsic…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the DPA of the participants. DPA is an
umbrella-term for total energy expenditure (cal), number of steps, average
METS, active energy expenditure (cal), physical activity duration (>=3 METS),
time spend on activities at sedentary (up to 3 METS), moderate (3-6 METS),
vigorous (6-9 METS) and very vigorous (9 METS and higher) intensity.
Secondary outcome
Scores on the following questionnaires are the secondary study parameters; the
Bandura*s Exercise Self-Efficacy Scale, the Self-Regulation
Questionnaire-Exercise, the Hospital Anxiety and Depression Scale, the Revised
Compliance Questionnaire, the Cardiac Attitudes Index, the Control Attitude
Scale, the Minimal Insomnia Symptom Scale and the Berlin Questionnaire.
Background summary
Heart failure (HF) has worldwide a high prevalence and mortality rate. Daily
physical activity (DPA) improves exercise tolerance and other symptoms of HF,
slow down the progression of the disease and improves survival rate. Up to now,
little is known about the performance based DPA status in HF patients. We
hypothesize that most HF patients are sedentary. In addition, we suggest DPA in
HF patients is affected by a number of psychosocial determinants like
self-efficacy, (intrinsic) motivation and depression.
Study objective
The main objective of this observational study is to examine DPA in HF patients
(NYHA II and III) by means of accelerometry. The secondary objective is to
assess the influence of a number of psychosocial determinants (e.g.
self-efficacy, intrinsic motivation and depression) on DPA.
Study design
A cross-sectional study will be used to examine DPA in HF patients and the
effect of a number of psychosocial determinants on DPA. We will include 75 out
clinic patients (NYHA II-III). DPA will be measured with the Sensewear Pro3
armband accelerometer (72 hours) and the SQUASH questionnaire. To measure the
psychosocial determinants which might be related to DPA, we will use Bandura*s
Exercise Self-Efficacy Scale, the Self-Regulation Questionnaire- Exercise, the
Hospital Anxiety and Depression Scale, the Revised Heart Failure Compliance
Questionnaire, the Minimal Insomnia Symptom Scale and the Berlin Questionnaire,
the Cardiac Attitudes Index and the Control Attitude Scale. All questionnaires
are valid and reliable.
Study burden and risks
Participation in the HEART*BEAT project is a minimal burden for the patients
and there are no disadvantages for the patients. The burden consists of filling
in a set of questionnaires and of wearing the Sensewear Armband for three days.
There are no risks in participating. There is no direct individually benefit
for the participants, but with the results of this study we await to develop a
relevant program, additional to usual rehab programs, to enhance DPA in HF
patients. This will be beneficial for the quality of life of HF patients.
Eysssoniusplein 18
9714 CE Groningen
Nederland
Eysssoniusplein 18
9714 CE Groningen
Nederland
Listed location countries
Age
Inclusion criteria
• Heart failure NYHA II-III
• Evidence of structural underlying heart disease
• Unchanged medication >= 4 weeks
• Age >= 18 years
• Able to walk or cycle
• Able to understand and fill in Dutch questionnaires
Exclusion criteria
• Life expectancy < 1 year
• Last six months Percutaneous Coronary Intervention/Coronary Artery Bypass Graft/Heart Transplantation/valvular replacement or planned such an intervention within the next 3 months
• Ventricle tachycardia (VT*s) and atrium fibrillation (AF) during increased physical activity
• Difficult to tune Diabetes Mellitus
• Recent lung embolism (<3 months ago) which is hemodynamic a burden
• Inclusion in another study
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 | NL30757.042.09 |