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

NCT04768283 | Unknown

• 1 other identifier: 2019-12-19 BE-2-107
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome; Ischaemic Heart Disease

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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 Arms (3)

Control group

NO INTERVENTION

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).

Intervention group 1

EXPERIMENTAL

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

Intervention group 2

EXPERIMENTAL

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

Interventions

Additional balance and resistance training - 1 OTHER

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.

Intervention group 1

Additional balance and resistance training - 2 OTHER

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.

Intervention group 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Kulautuva, Kaunas County, Lithuania

RECRUITING

MeSH Terms

Conditions

Frailty; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Aurelija Beigienė, MD

CONTACT

+37065875579; aurelija.beigiene@kaunoklinikos.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aurelija Beigienė, MD

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: January 6, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)