NCT05326529

Comparison of Traditional, Web-based or a Combined Cardiac Rehabilitation Programme

Completed NA Results posted Last updated 28 August 2024

What this trial tests

NA trial testing Hospital Based Cardiac Rehabilitation Exercise Classes in Cardiovascular Diseases in 57 participants. Completed in 28 February 2023.

Timeline

7 July 2022

Primary endpoint
28 February 2023

28 February 2023

Quick facts

Lead sponsor	University of Chester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	7 July 2022
Primary completion	28 February 2023
Estimated completion	28 February 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Hospital Based Cardiac Rehabilitation Exercise Classes
• Web-based Cardiac Rehabilitation Exercise Sessions

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

University of Chester

Who can join

Adults 50 to 70, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention. Primary · The Walk Test will be completed pre and post intervention (8 weeks apart)

An Incremental Shuttle Walk test will be performed to determine the Metabolic equivalent achieved at each level. Metabolic Equivalent (1 MET) is defined as the amount of energy required to serve the body's energy needs. This will range from 1 METs = lowest energy requirement to 10.9 METs highest energy requirement for completing the test. Walking at a slower pace requires a lower level of energy expenditure and is therefore considered a light-intensity activity, walking at a faster pace requires a higher energy expenditure and is therefore considered a higher-intensity activity. The higher the

Pre intervention

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	5.9	5.5 – 6.4
Traditional Combined With Web-based Cardiac Rehabilitation	5.8	5.4 – 6.2
Web-based Cardiac Rehabilitation	5.6	5.2 – 6.0

Post Intervention

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	7.4	6.9 – 7.9
Traditional Combined With Web-based Cardiac Rehabilitation	7.3	6.9 – 7.7
Web-based Cardiac Rehabilitation	6.5	6.1 – 7.0

Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention Secondary · Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)

This will be evaluated through participants completing a Hospital Anxiety and Depression questionnaire. Scoring range: 0-7 = normal range, 8-10 = borderline abnormal,11-21 abnormal and treatment is indicated. The questionnaire comprises of 7 questions for Anxiety and 7 for Depression with a total score for each ranging from 1-21. The scores will be reported separately for Anxiety and depression. The higher the score the worse the outcome for the participant as this indicates a higher level of either anxiety or depression.

Pre Intervention (Anxiety Score)

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	4.95	± 3.1
Traditional Combined With Web-based Cardiac Rehabilitation	4.56	± 3.05
Web-based Cardiac Rehabilitation	5.65	± 3.25

Post Intervention (Anxiety Score)

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	3.68	± 2.45
Traditional Combined With Web-based Cardiac Rehabilitation	4.00	± 3.77
Web-based Cardiac Rehabilitation	4.53	± 2.98

Pre Intervention (Depression Score)

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	4.53	± 3.58
Traditional Combined With Web-based Cardiac Rehabilitation	3.28	± 2.42
Web-based Cardiac Rehabilitation	4.59	± 3.22

Post Intervention (Depression Score)

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	3.16	± 2.47
Traditional Combined With Web-based Cardiac Rehabilitation	2.44	± 2.09
Web-based Cardiac Rehabilitation	3.94	± 3.03

Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention. Secondary · Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)

This will be evaluated through participants completing a questionnaire consisting of questions measuring health status, physical fitness, feelings, daily activities, social activities, change in health status, current overall health perceptions and bodily pain. Each question gives 5 response options, 1= very good, 2= good, 3= Moderate, 4=Bad, 5= Very Bad. Minimum score = 9, maximum score 45. Total score gives a profile of health status i.e, higher total score = poor health status. The scores will be evaluated at baseline and after 8 weeks of intervention. The score should be lower after 8 week

Pre Intervention

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	21.9	± 5.63
Traditional Combined With Web-based Cardiac Rehabilitation	20.1	± 5.01
Web-based Cardiac Rehabilitation	21.35	± 5.38

Post Intervention

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	16.4	± 3.57
Traditional Combined With Web-based Cardiac Rehabilitation	15.7	± 2.63
Web-based Cardiac Rehabilitation	17.41	± 4.50

Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention Secondary · The Walk Test will be completed pre and post intervention (8 weeks apart)

An Incremental Shuttle Walk test will be performed to evaluate functional capacity and determine what percentage of predicted heart rate the participant has achieved at each level of the walk test. The maximum Heart Rate achieved at the end of the walk test will then be converted to walking speed index (HRWSI). This will be converted using the BACPR HRWSI table which looks at the number of heart beats for every 10 meters walked when completing a standardised walking test. HRWSI is calculated by dividing Heart rate by the walking speed (meters per minute) multiplied by 10 to give heart beats pe

Pre Intervention

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	11.3	10.2 – 12.5
Traditional Combined With Web-based Cardiac Rehabilitation	11.3	10.5 – 12.1
Web-based Cardiac Rehabilitation	12.2	11.1 – 13.3

Post Intervention

Group	Value	95% CI
Traditional Cardiac Rehabilitation (Hospital Based Programme)	10.2	9.3 – 11.1
Traditional Combined With Web-based Cardiac Rehabilitation	10.2	9.6 – 10.8
Web-based Cardiac Rehabilitation	10.9	9.8 – 12.2

Sponsor's own description

The study explores the different modes of Cardiac Rehabilitation delivery including the use of a web-based programme. Cardiac Rehabilitation provides a structured, comprehensive programme, proven to reduce cardiovascular mortality and improve overall Quality of Life. However, as uptake remains relatively low with only 50% attending, exploring the benefits of offering a menu of programme options may allow greater patient choice and accessibility, meeting individual needs.

This study aims to compare how effective Cardiac Rehabilitation Programmes are on improving cardiovascular patients physical and mental wellbeing using a web-based compared with traditional cardiac rehab programmes in the hospital or through a combination of both.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Home-based versus centre-based cardiac rehabilitation.
   McDonagh ST, Dalal H, Moore S, Clark CE, et al · · 2023 · cited 58× · PMID 37888805 · DOI 10.1002/14651858.cd007130.pub5