Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Queen's University, Belfast |
---|---|
Information provided by: | Queen's University, Belfast |
ClinicalTrials.gov Identifier: | NCT00219830 |
The purpose of this study is to investigate if a home-based walking program is an acceptable alternative for those who choose not to attend formal cardiac rehabilitation programs and if such a program has an effect on coronary risk or physical fitness.
Condition | Intervention |
---|---|
Acute Myocardial Infarction |
Behavioral: cardiac rehabilitation program |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Health and Social Inequalities in the Uptake of Cardiac Rehabilitation in Northern Ireland: an Alternative Program for Non-Attenders: (2) a Randomised Controlled Trial. |
Enrollment: | 432 |
Study Start Date: | January 2005 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
Attended formal cardiac rehabilitation after myocardial infarction
|
Behavioral: cardiac rehabilitation program
Attended a formal cardiac rehabilitation program/did not attend
|
2
Did not attend Cardiac Rehabilitation following myocardial infarction
|
Behavioral: cardiac rehabilitation program
Attended a formal cardiac rehabilitation program/did not attend
|
Coronary heart disease (CHD) is the most important cause of life years lost in Northern Ireland (NI). A recently updated Cochrane review (Joliffe et al, 2003) confirmed the findings of earlier meta-analyses (O'Connor et al, 1989; Oldridge et al, 1988) which indicated that participation in cardiac rehabilitation (CR) reduces mortality after MI. The earlier work demonstrated a reduction of 20-25% in all-cause and cardiac mortality. The recent work allowed analysis of an increased number of patients (8440 in 32 trials) and reported a reduction in total cardiac mortality of up to 31%. Participation in CR after MI also improves well-being and reduces disability (NHS, 1998). However, informal reports suggest that only approximately 50% of patients actually attend a hospital based program.
The hypothesis to be tested is that for those who chose not to attend formal CR, a home-based walking program is an acceptable alternative.
This programme of work entails two separate study designs. To evaluate the home-based walking program, we plan a randomised controlled trial (RCT).
Randomisation of subjects to study groups will follow determination of eligibility to participate. Participants randomised to the experimental group will be asked to walk for up to 30 minutes, 5-days per week. They will be requested to record aspects of their walking in a diary, including time, intensity and number of steps taken (recorded using a pedometer).
Qualitative methodology using semi-structured interviews will be used to explore the experiences of those allocated to the intervention group. The attitudes and experiences of other non-attenders of CR who declined to participate in the trial will be explored in focus groups. Three focus groups each containing 8 participants are planned.
Focus group transcripts will be analysed independently by two observers using a computer program (NUDIST) to identify themes and develop questions for the semi-structured interviews. Analysis of the semi-structured interviews will be descriptive, responses being categorised into themes as appropriate. RCT results will be analysed by intention to treat.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients registered in selected general practices who had a record of having had a myocardial infarction 12 weeks previous to identification point
Inclusion Criteria:
Exclusion Criteria - planned for RCT - applied to small pilot:
United Kingdom, Northern Ireland | |
Dept of General Practice | |
Belfast, Northern Ireland, United Kingdom, BT9 7HR |
Principal Investigator: | Margaret E Cupples, MD | Queen's University, Belfast |
Principal Investigator: | Mark A Tully, PhD | Queen's University, Belfast |
Responsible Party: | Queen's University Belfast ( Margaret Cupples ) |
Study ID Numbers: | COM2376-02-02 |
Study First Received: | September 19, 2005 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00219830 History of Changes |
Health Authority: | United Kingdom: National Health Service |
Cardiac Rehabilitation Walking Acute Myocardial Infarction Secondary Prevention |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Neoplasm Metastasis Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |