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

NCT ID: NCT04768283

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2022-10-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Additional balance and resistance training - 1

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Additional balance and resistance training - 2

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Aurelija Beigienė

Aurelija Beigienė, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Kulautuva, Kaunas County, Lithuania

Site Status: RECRUITING

Countries

Lithuania

Central Contacts

Aurelija Beigienė, MD

Role: CONTACT

aurelija.beigiene@kaunoklinikos.lt

+37065875579

Facility Contacts

Aurelija Beigienė, MD

Role: primary

aurelija.beigiene@lsmuni.lt

+37065875579

Other Identifiers

2019-12-19 BE-2-107

Identifier Type: -

Identifier Source: org_study_id