A Trial of a Home Based Walking Program as an Alternate Program for Non Attenders at Cardiac Rehabilitation

NCT ID: NCT00219830

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

home-based walking program

Intervention Type: BEHAVIORAL

Home-based walking program; included use of pedometer and daily walk diary

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'

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

home-based walking program

Home-based walking program; included use of pedometer and daily walk diary

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Justification of diagnosis of myocardial infarction by report of cardiac bio-markers or electrocardiogram changes

Exclusion Criteria

• Heart failure/ Cardiogenic shock
• Complex ventricular arrhythmias
• Mental/physical impairment (exclude if housebound/dementia)
• Valve disorder-severe stenotic or regurgitant lesion
• Hypertrophic cardiomyopathy
• Exercise Stress Test result- exclude if ST depression>=2 mm or angina at <5 Metabolic Equivalent of Tasks (METS) (e.g. 3 minutes of a Bruce protocol). (Also exclude if report of ST segment depression >=1 mm on resting ECG )

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Dr Margaret E Cupples

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret E Cupples, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Mark A Tully, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Dept of General Practice

Belfast, Northern Ireland, United Kingdom

Countries

United Kingdom

References

Tully M, Cupples ME, Young IS et al. CRU-SHAL Study - provision and uptake of cardiac rehabilitation in Northern Ireland. British Association for Cardiac Rehabilitation Annual Conference: Emerging Challenges for Cardiac Rehabilitation. September 2006, p10.

Reference Type: BACKGROUND

Other Identifiers

COM2376-02-02

Identifier Type: -

Identifier Source: org_study_id