A Trial of a Home Based Walking Program as an Alternate Program for Non Attenders at Cardiac Rehabilitation (CRU-SHAL)

This study has been completed.
Sponsor:
Information provided by:
Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT00219830
First received: September 19, 2005
Last updated: February 18, 2009
Last verified: February 2009
  Purpose

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: Observational Model: Case Control
Time Perspective: 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.

Resource links provided by NLM:


Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • Quality of Life Score [ Time Frame: 16-20 weeks post myocardial infarction ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients registered in selected general practices who had a record of having had a myocardial infarction 12 weeks previous to identification point

Criteria

Inclusion Criteria:

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

Exclusion Criteria - planned for RCT - applied to small pilot:

  • 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 METS (e.g. 3 minutes of a Bruce protocol). (Also exclude if report of ST segment depression >=1 mm on resting ECG )
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219830

Locations
United Kingdom
Dept of General Practice
Belfast, Northern Ireland, United Kingdom, BT9 7HR
Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Margaret E Cupples, MD Queen's University, Belfast
Principal Investigator: Mark A Tully, PhD Queen's University, Belfast
  More Information

No publications provided

Responsible Party: Margaret Cupples, Queen's University Belfast
ClinicalTrials.gov Identifier: NCT00219830     History of Changes
Other Study ID Numbers: COM2376-02-02
Study First Received: September 19, 2005
Last Updated: February 18, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by Queen's University, Belfast:
Cardiac Rehabilitation
Walking
Acute Myocardial Infarction
Secondary Prevention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014