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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty Syndrome; Ischaemic Heart Disease
• Intervention / Treatment: Other: Additional balance and resistance training - 1; Other: Additional balance and resistance training - 2

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurelija Beigienė, MD; Phone Number: +37065875579; Email: aurelija.beigiene@kaunoklinikos.lt

Study Locations

• Lithuania
  • Kaunas
    • Kulautuva, Kaunas, Lithuania
      • Recruiting
      • LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
      • Contact: Aurelija Beigienė, MD; Phone Number: +37065875579; Email: aurelija.beigiene@lsmuni.lt
      • Principal Investigator: Daiva Petruševičienė, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Cardiac rehabilitation physical training program included: respiratory muscle training (7 days/week, for 15 minutes) and aerobic exercises on cycle ergometers (6 days/week, for 10-30 minutes, 30-50% watts or 30-50% HRmax).
Experimental: Intervention group 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.	Other: Additional balance and resistance training - 1; Additional exercise program with balance and resistance training three times per week. The balance training included exercises to improve static as well as dynamic balance ability, for 15-20 minutes. The resistance training included exercises with weights (0,5, 1 or 2 kg), elastic resistance rubbers, intensity 30-50% 1-RM, 10 repetitions with 3 sets and 3 minute rest between sets.
Experimental: Intervention group 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.	Other: Additional balance and resistance training - 2; Additional exercise program with balance and resistance training three times per week. The balance training included exercises with static and dynamic balance training device Biodex Balance System TM SD, for 15-20 minutes. Exercises are performed with the following programs: Postural stability training, Limits of stability training, Weight shift training, Maze control training, Random control training, Percent weight-bearing training. The resistance training included exercises with HUR strength training machines, intensity 30-50% 1-RM, 10 repetitions with 3 sets and 3 minute rest between sets. Strength training was performed with the following exercises: Leg press, leg extension, leg abduction, leg adduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty level by Edmonton frail scale score	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.	baseline
Change from baseline functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	baseline, 3 weeks
Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	baseline, 3 weeks
Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)	PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute	baseline, 3 weeks
Change from baseline quality of life by MacNew questionnaire	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.	baseline, 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline physical performance by Short Physical Performance Battery (SPPB)	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).	baseline, 3 weeks
Change from baseline muscular strength by one repetition maximum test (1RM)	1RM test for leg extension measured by kilograms	baseline, 3 weeks

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac rehabilitation; Balance training; Exercise training; Frailty; Cardiac surgery; Resistance training
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Syndrome; Frailty
• Other Study ID Numbers: 2019-12-19 BE-2-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No