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

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ClinicalTrials.gov Identifier: NCT00219830
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Margaret E Cupples, Queen's University, Belfast

September 19, 2005
September 22, 2005
May 18, 2018
January 2005
May 2007   (Final data collection date for primary outcome measure)
Quality of Life Score [ Time Frame: 16-20 weeks post myocardial infarction ]
MacNew Post-myocardial infarction questionnaire score
  • Fitness
  • Blood Pressure
  • High Density Lipoproteins
Complete list of historical versions of study NCT00219830 on ClinicalTrials.gov Archive Site
Not Provided
  • Heart rate
  • Quality of Life score
  • Body mass index
Not Provided
Not Provided
 
A Trial of a Home Based Walking Program as an Alternate Program for Non Attenders at Cardiac Rehabilitation
Health and Social Inequalities in the Uptake of Cardiac Rehabilitation in Northern Ireland: an Alternative Program for Non-attenders: (2) a Randomised Controlled Trial.
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.

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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Acute Myocardial Infarction
Behavioral: home-based walking program
Home-based walking program; included use of pedometer and daily walk diary
  • 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
    Intervention: Behavioral: home-based walking program
  • 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'
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
80
May 2007
May 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Justification of diagnosis of myocardial infarction 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 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 )
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00219830
COM2376-02-02
No
Not Provided
Plan to Share IPD: No
Plan Description: No plan to share individual participant data - these will form an aggregated database for determination of the design of a later definitive study.
Dr Margaret E Cupples, Queen's University, Belfast
Queen's University, Belfast
Not Provided
Principal Investigator: Margaret E Cupples, MD Queen's University, Belfast
Principal Investigator: Mark A Tully, PhD Queen's University, Belfast
Queen's University, Belfast
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP