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

Frailty Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04768283
• Other study ID #: 2019-12-19 BE-2-107
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: March 2021
• Source: Lithuanian University of Health Sciences
• Contact: Aurelija Beigiene, MD
• Phone: +37065875579
• Email: aurelija.beigiene[@]kaunoklinikos.lt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Frailty
• Frailty Syndrome
• Heart Diseases
• Ischaemic Heart Disease
• Myocardial Ischemia
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Lithuania	LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva	Kulautuva	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	baseline, 3 weeks
Primary	Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	baseline, 3 weeks
Primary	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
Primary	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	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
Secondary	Change from baseline muscular strength by one repetition maximum test (1RM)	1RM test for leg extension measured by kilograms	baseline, 3 weeks