Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219830
Status:
WITHDRAWN
Last Update Posted:
2022-02-08
First Post:
2005-09-19
Brief Title:
A Trial of a Home Based Walking Program as an Alternate Program for Non Attenders at Cardiac Rehabilitation
Sponsor:
Queens University Belfast
Organization:
Queens University Belfast
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no invited participants agreed to undertake the proposed intervention
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRU-SHAL
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 OConnor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None