NCT00219830

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

September 19, 2005

Last Update Submit

February 4, 2022

Conditions

Keywords

Cardiac RehabilitationWalkingAcute Myocardial InfarctionSecondary Prevention

Outcome Measures

Primary Outcomes (1)

  • Quality of Life Score

    MacNew Post-myocardial infarction questionnaire score

    16-20 weeks post myocardial infarction

Study Arms (2)

1 - home-based walking program

EXPERIMENTAL

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

2 - cardiac rehabilitation

NO INTERVENTION

Based on medical record held in general practice, patients who are identified as having attended a Cardiac Rehabilitation program following myocardial infarction - 'usual care'

Interventions

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

1 - home-based walking program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of General Practice

Belfast, Northern Ireland, BT9 7HR, United Kingdom

Location

Related Publications (1)

  • 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.

    BACKGROUND

Study Officials

  • Margaret E Cupples, MD

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR
  • Mark A Tully, PhD

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

January 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

February 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data - these will form an aggregated database for determination of the design of a later definitive study.

Locations