NCT05264701

Brief Summary

This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 19, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

2.1 years

First QC Date

February 19, 2022

Last Update Submit

June 17, 2024

Conditions

Keywords

Cardiac RehabilitationExercise Training

Outcome Measures

Primary Outcomes (2)

  • Exercise Capacity

    Exercise capacity will be evaluated using the incremental shuttle walk test.

    Baseline, after 12 weeks, after 24 weeks

  • Participation

    Participation will be evaluated using the number of sessions attended.

    after 12 weeks

Secondary Outcomes (6)

  • Maximal Effort Capacity

    Baseline

  • Peripheral muscle strength

    Baseline, after 12 weeks, after 24 weeks

  • Endothelial function

    Baseline, after 12 weeks, after 24 weeks

  • Healthy Living Habit Evaluation

    Baseline, after 12 weeks, after 24 weeks

  • Health-Related Quality of Life

    Baseline, after 12 weeks, after 24 weeks

  • +1 more secondary outcomes

Study Arms (3)

Physiotherapist Supervised Exercise Training Group

EXPERIMENTAL

Physiotherapist supervised exercise training in patients with coronary artery disease

Other: Physiotherapist supervised exercise training

Exercise Training Tracking from Phone-app Group

EXPERIMENTAL

Exercise training tracking from phone app in patients with coronary artery disease

Other: Exercise training via phone app

Control Group

EXPERIMENTAL

General physical activity recommendations for home

Other: Physical activity recommendations

Interventions

Exercise training for 12 weeks will be given by video talk accompanied by a physiotherapist.

Physiotherapist Supervised Exercise Training Group

Exercise training for 12 weeks will be given over the developed phone application.

Exercise Training Tracking from Phone-app Group

The program will be consist of 12 weeks of physical activity recommendations.

Control Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with coronary artery disease
  • Access to the online program
  • Volunteering to participate in the research
  • Having an iOS or Android operating system compatible phone

You may not qualify if:

  • Having a musculoskeletal problem
  • Having uncontrolled hypertension
  • Having chronic heart failure (NYHA III-IV)
  • A history of acute coronary syndrome or surgical revascularization less than 12 months ago
  • More than 50% occlusion on the main coronary artery
  • Having arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery DiseaseSedentary Behavior

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavior

Study Officials

  • Naciye Vardar-Yagli, PhD

    Hacettepe University

    STUDY DIRECTOR
  • Hikmet Yorgun, PhD

    Hacettepe University

    STUDY DIRECTOR
  • Ahmet Hakan Ates, PhD

    Hacettepe University

    STUDY CHAIR
  • Deniz Yuce, PhD

    Hacettepe University

    STUDY CHAIR
  • Dilara Saklica, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 3, 2022

Study Start

April 7, 2022

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations