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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

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Behavioral: home-based walking program Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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'



Primary Outcome Measures :
  1. Quality of Life Score [ Time Frame: 16-20 weeks post myocardial infarction ]
    MacNew Post-myocardial infarction questionnaire score



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 )

Information from the National Library of Medicine

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


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

Publications:
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.

Responsible Party: Dr Margaret E Cupples, Professor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT00219830     History of Changes
Other Study ID Numbers: COM2376-02-02
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by Dr Margaret E Cupples, 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