Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention

The aim of the study is to evaluate the short- and medium-term effectiveness of additional moderate dynamic resistance and balance training to the CR-program of old adults after valve surgery or intervention compared to usual care-CR.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Frailty Syndrome; Valve Heart Disease
• Intervention / Treatment: Other: Additional balance and resistance training

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kulautuva
    • Kaunas, Kulautuva, Lithuania
      • LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients after valve surgery and/or intervention
• Age 65 years and older
• Ability to start CR within 4 weeks after surgery,
• 6-minute walk distance (6-MWD) ≥100- ≤350 m (1)
• Patient's agreement to participate in the study.

Exclusion Criteria:

• 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 CR according to study protocol), including chronic heart failure New York Heart Association Class IV, hemoglobin less than 9 g/dL, wound healing disturbance, cognitive or linguistic deficits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; The supervised exercise program included: continues endurance training on cycle ergometers (6 sessions a week). Every session included warm up (<50% target intensity 2 min, gradually increasing load 1-10 w/min up to target intensity within 5 - 10 min); exercise phase (100% of the target intensity (30-50% watts or 30-50% HRmax), starting with >5 minutes and gradually prolonged up to 30 min); cool down with gradual reduction of the load within 3 minutes); additional aerobic exercises performed sitting and/or standing (30 minutes, 5 days/week); respiratory muscle training (7 days/week, for 15 minutes) using ball trainer.
OTHER: Intervention group; Exercise program as for a control group together with additional resistance and balance training 3 sessions/week. The resistance training was started with low intensity (<30% 1-RM, RPE ≤ 11, 5-10 repetitions), increased gradually to moderate intensity (30-50% and up to 60% 1-RM, RPE 12-13, after 8-15 repetitions) with 3 sets and 3 minute rest between sets, if tolerated. The balance training included exercises to improve static as well as dynamic balance ability. It was performed on 2-3 days/week for 10-15 minutes. The complexity of the balance exercises was selected and incremented individually by changing the stand-position, the base on which the stands were performed and/or using unstable surfaces. If tolerated, the visual information was varied and/or additional tasks performed while balancing. After completion participants were encouraged to continue exercise training at home according to recommendations.	Other: Additional balance and resistance training; Additional exercise program with balance and resistance training three times per week. After completion participants are encouraged to continue exercise training at home according to recommendations and will receive control calls every two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical performance by Short Physical Perfromance 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
Physical performance by Short Physical Perfromance 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).	20 days
Physical performance by Short Physical Perfromance 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).	Three months
Physical performance by 5 meters walking test (5MWT)	5MWT is a gate speed test measured by meters per second.	Baseline
Physical performance by 5 meters walking test (5MWT)	5MWT is a gate speed test measured by meters per second.	20 days
Physical performance by 5 meters walking test (5MWT)	5MWT is a gate speed test measured by meters per second.	3 months
Functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	Baseline
Functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	20 days
Functional capacity by six minutes walking test (6MWT)	6MWT measured by meters	3 months
Quality of life by questionnaire Short Form Survey SF-36	0-100%, the higher score, the better quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) in units on the scale	Baseline
Quality of life by questionnaire Short Form Survey SF-36	0-100%, the higher score, the better quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) in units on the scale	20 days
Quality of life by questionnaire Short Form Survey SF-36	0-100%, the higher score, the better quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) in units on the scale	3 months
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)	Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life	Baseline
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)	Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life	20 days
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)	Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life	3 months
Quality of life by questionnaire EQ-5D	EQ-5D in units on the scale, 0-10, the higher score, the better quality of life	Baseline
Quality of life by questionnaire EQ-5D	EQ-5D in units on the scale, 0-10, the higher score, the better quality of life	20 days
Quality of life by questionnaire EQ-5D	EQ-5D in units on the scale, 0-10, the higher score, the better quality of life	3 months
Quality of life by questionnaire Quality of Life: Cardiac Index	Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life	Baseline
Quality of life by questionnaire Quality of Life: Cardiac Index	Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life	20 days
Quality of life by questionnaire Quality of Life: Cardiac Index	Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty level by SPPB score	Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.	baseline
Frailty level by SPPB score	Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.	20 days
Frailty level by SPPB score	Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.	three months
Frailty level by 5MWT	Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust	baseline
Frailty level by 5MWT	Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust	20 days
Frailty level by 5MWT	Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust	three months
Physical activity by International physical activity questionnaire (IPAQ)	IPAQ in units on the scale	3 months
Physical activity by International physical activity questionnaire (IPAQ)	IPAQ in units on the scale	20 days
Physical activity by International physical activity questionnaire (IPAQ)	IPAQ in units on the scale	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
Cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	Baseline
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)	PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute	20 days
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)	PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute	3 months
Cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	20 days
Cardiopulmonary exercise capacity by maximal load (maxWatt)	Maximal load measured with spiroergometry by maximal watts	3 months
Muscular strength by one repetition maximum test (1RM)	1RM test for leg extension measured by kilograms	baseline
Muscular strength by one repetition maximum test (1RM)	1RM test for leg extension measured by kilograms	20 days
Muscular strength by one repetition maximum test (1RM)	1RM test for leg extension measured by kilograms	3 months

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Principal Investigator: Raimondas Kubilius, Prof, Lithuanian University of Health Sciences, Department of Rehabilitation

Publications and helpful links

General Publications

• Tamuleviciute-Prasciene E, Beigiene A, Thompson MJ, Balne K, Kubilius R, Bjarnason-Wehrens B. The impact of additional resistance and balance training in exercise-based cardiac rehabilitation in older patients after valve surgery or intervention: randomized control trial. BMC Geriatr. 2021 Jan 7;21(1):23. doi: 10.1186/s12877-020-01964-3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2018
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: January 12, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (ACTUAL): January 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac rehabilitation; Balance training; Exercise training; Resistance training; Physical capacity; Functional capacity; Valve surgery; Valve intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Frailty; Heart Valve Diseases
• Other Study ID Numbers: LUHS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No