Back to resultsCardiac Rehabilitation and Additional Physical Training in Elderly Patients After Acute Coronary Syndrome
Primary Purpose
Frailty Syndrome, Ischaemic Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Additional balance and resistance training - 1
Additional balance and resistance training - 2
Sponsored by
About this trial
This is an interventional treatment trial for Frailty Syndrome focused on measuring Frailty, Cardiac surgery, Cardiac rehabilitation, Exercise training, Resistance training, Balance training
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.
Sites / Locations
- LUHS hospital Kaunas Clinics Rehabilitation hospital of KulautuvaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control group
Intervention group 1
Intervention group 2
Arm Description
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).
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.
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.
Outcomes
Primary Outcome Measures
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.
Change from baseline functional capacity by six minutes walking test (6MWT)
6MWT measured by meters
Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)
Maximal load measured with spiroergometry by maximal watts
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
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.
Secondary Outcome Measures
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).
Change from baseline muscular strength by one repetition maximum test (1RM)
1RM test for leg extension measured by kilograms
Full Information
NCT ID
NCT04768283
First Posted
February 21, 2021
Last Updated
March 2, 2021
Sponsor
Lithuanian University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04768283
Brief Title
Cardiac Rehabilitation and Additional Physical Training in Elderly Patients After Acute Coronary Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty Syndrome, Ischaemic Heart Disease
Keywords
Frailty, Cardiac surgery, Cardiac rehabilitation, Exercise training, Resistance training, Balance training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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).
Arm Title
Intervention group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Additional balance and resistance training - 1
Intervention Description
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
Intervention Name(s)
Additional balance and resistance training - 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frailty level by Edmonton frail scale score
Description
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.
Time Frame
baseline
Title
Change from baseline functional capacity by six minutes walking test (6MWT)
Description
6MWT measured by meters
Time Frame
baseline, 3 weeks
Title
Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)
Description
Maximal load measured with spiroergometry by maximal watts
Time Frame
baseline, 3 weeks
Title
Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Description
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Time Frame
baseline, 3 weeks
Title
Change from baseline quality of life by MacNew questionnaire
Description
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.
Time Frame
baseline, 3 weeks
Secondary Outcome Measure Information:
Title
Change from baseline physical performance by Short Physical Performance Battery (SPPB)
Description
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).
Time Frame
baseline, 3 weeks
Title
Change from baseline muscular strength by one repetition maximum test (1RM)
Description
1RM test for leg extension measured by kilograms
Time Frame
baseline, 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelija Beigienė, MD
Phone
+37065875579
Email
aurelija.beigiene@kaunoklinikos.lt
Facility Information:
Facility Name
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
City
Kulautuva
State/Province
Kaunas
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelija Beigienė, MD
Phone
+37065875579
Email
aurelija.beigiene@lsmuni.lt
First Name & Middle Initial & Last Name & Degree
Daiva Petruševičienė, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiac Rehabilitation and Additional Physical Training in Elderly Patients After Acute Coronary Syndrome
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