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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04768283
Enrollment
100
Registered
2021-02-24
Start date
2020-01-06
Completion date
2022-10-30
Last updated
2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty Syndrome, Ischaemic Heart Disease

Keywords

Frailty, Cardiac surgery, Cardiac rehabilitation, Exercise training, Resistance training, Balance training

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.

Interventions

OTHERAdditional 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.

OTHERAdditional 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.

Sponsors

Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline functional capacity by six minutes walking test (6MWT)baseline, 3 weeks6MWT measured by meters
Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)baseline, 3 weeksPeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Change from baseline quality of life by MacNew questionnairebaseline, 3 weeksThe 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.
Frailty level by Edmonton frail scale scorebaselineFrailty 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 cardiopulmonary exercise capacity by maximal load (maxWatt)baseline, 3 weeksMaximal load measured with spiroergometry by maximal watts

Secondary

MeasureTime frameDescription
Change from baseline muscular strength by one repetition maximum test (1RM)baseline, 3 weeks1RM test for leg extension measured by kilograms
Change from baseline physical performance by Short Physical Performance Battery (SPPB)baseline, 3 weeksThe 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).

Countries

Lithuania

Contacts

Primary ContactAurelija Beigienė, MD
aurelija.beigiene@kaunoklinikos.lt+37065875579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026