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Clinical Trials/NCT04768283
NCT04768283
Unknown
N/A

Evaluation of Cardiac Rehabilitation Functional and Physical Capacity, Health-related Quality of Life and Associations With Frailty in Older Patients After Ischemic Heart Disease and Interventional Treatment

Lithuanian University of Health Sciences1 site in 1 country100 target enrollmentJanuary 6, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frailty Syndrome
Sponsor
Lithuanian University of Health Sciences
Enrollment
100
Locations
1
Primary Endpoint
Frailty level by Edmonton frail scale score
Last Updated
5 years ago

Overview

Brief Summary

The aim of this study is to evaluate functional and physical capacity, health-related quality of life and associations with frailty in older patients after ischemic heart disease and interventional treatment with an individualized physical training program in the second phase of cardiac rehabilitation.

Registry
clinicaltrials.gov
Start Date
January 6, 2020
End Date
October 30, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aurelija Beigienė

Aurelija Beigienė, MD

Lithuanian University of Health Sciences

Eligibility Criteria

Inclusion Criteria

  • Patients after acute coronary syndrome and percutaneous coronary intervention or coronary bypass surgery;
  • Age 65 years and older;
  • 6-minute walk distance (6-MWD) ≥150 meters;
  • Left ventricular ejection fraction ≥ 40%;
  • Patient's agreement to participate in the study.

Exclusion Criteria

  • combined coronary artery bypass grafting and valve surgery;
  • Cardiac devices;
  • Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
  • Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive or linguistic deficits.

Outcomes

Primary Outcomes

Frailty level by Edmonton frail scale score

Time Frame: baseline

Frailty measured by The Edmonton frail scale score - 0-3 - fit, 4-5 - vulnerable, 6-7 - mild frailty, 8-9 - moderate frailty,10-17 - severe frailty.

Change from baseline quality of life by MacNew questionnaire

Time Frame: baseline, 3 weeks

The MacNew Heart Disease HRQL questionnaire consists of 27 items which fall into three domains (a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale). There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The time frame for the MacNew is the previous two weeks.

Change from baseline functional capacity by six minutes walking test (6MWT)

Time Frame: baseline, 3 weeks

6MWT measured by meters

Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)

Time Frame: baseline, 3 weeks

Maximal load measured with spiroergometry by maximal watts

Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)

Time Frame: baseline, 3 weeks

PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute

Secondary Outcomes

  • Change from baseline physical performance by Short Physical Performance Battery (SPPB)(baseline, 3 weeks)
  • Change from baseline muscular strength by one repetition maximum test (1RM)(baseline, 3 weeks)

Study Sites (1)

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