Cardiac Rehabilitation and Additional Physical Training in Elderly Patients After Acute Coronary Syndrome

Not Applicable

• Conditions: Frailty Syndrome; Ischaemic Heart Disease
• Interventions: Other: Additional balance and resistance training - 2; Other: Additional balance and resistance training - 1

• Registration Number: NCT04768283
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-24
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group 2	Additional balance and resistance training - 2	Combinated physical training program: Respiratory exercises, aerobic training will be the same as in the control group. Additional exercises: balance training with static and dynamic balance training device Biodex Balance System TM SD and strength exercises with HUR strength training machines.
Intervention group 1	Additional balance and resistance training - 1	Combinated physical training program: Respiratory exercises, aerobic training will be the same as in the control group. Additional exercises: balance training and strength exercises with weights, elastic resistance rubbers.

Primary Outcome Measures

Name	Time	Method
Frailty level by Edmonton frail scale score	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	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)	baseline, 3 weeks	6MWT measured by meters
Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)	baseline, 3 weeks	Maximal load measured with spiroergometry by maximal watts
Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)	baseline, 3 weeks	PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute

Secondary Outcome Measures

Name	Time	Method
Change from baseline physical performance by Short Physical Performance Battery (SPPB)	baseline, 3 weeks	The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.The scores range from 0 (worst performance) to 12 (best performance).
Change from baseline muscular strength by one repetition maximum test (1RM)	baseline, 3 weeks	1RM test for leg extension measured by kilograms

Trial Locations

Locations (1)

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva; 🇱🇹 Kulautuva, Kaunas, Lithuania