A Trial of a Home Based Walking Program as an Alternate Program for Non Attenders at Cardiac Rehabilitation (CRU-SHAL)
|ClinicalTrials.gov Identifier: NCT00219830|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Behavioral: home-based walking program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
Experimental: 1 - home-based walking program
Based on medical record held in general practice, patients who had not attended a formal cardiac rehabilitation program after myocardial infarction and were enrolled in home-based walking programme
Behavioral: home-based walking program
Home-based walking program; included use of pedometer and daily walk diary
No Intervention: 2 - cardiac rehabilitation
Based on medical record held in general practice, patients who are identified as having attended a Cardiac Rehabilitation program following myocardial infarction - 'usual care'
- Quality of Life Score [ Time Frame: 16-20 weeks post myocardial infarction ]MacNew Post-myocardial infarction questionnaire score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219830
|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|