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

Sponsor

Lithuanian University of Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04234087

Collaborator

(none)

116

Enrollment

Location

Arms

28.1

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty Syndrome Quality of Life Valve Heart Disease	Other: Additional balance and resistance training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 26, 2018

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Physical performance by Short Physical Perfromance Battery (SPPB) [Baseline]
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).
Physical performance by Short Physical Perfromance Battery (SPPB) [20 days]
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).
Physical performance by Short Physical Perfromance Battery (SPPB) [Three months]
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).
Physical performance by 5 meters walking test (5MWT) [Baseline]
5MWT is a gate speed test measured by meters per second.
Physical performance by 5 meters walking test (5MWT) [20 days]
5MWT is a gate speed test measured by meters per second.
Physical performance by 5 meters walking test (5MWT) [3 months]
5MWT is a gate speed test measured by meters per second.
Functional capacity by six minutes walking test (6MWT) [Baseline]
6MWT measured by meters
Functional capacity by six minutes walking test (6MWT) [20 days]
6MWT measured by meters
Functional capacity by six minutes walking test (6MWT) [3 months]
6MWT measured by meters
Quality of life by questionnaire Short Form Survey SF-36 [Baseline]
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
Quality of life by questionnaire Short Form Survey SF-36 [20 days]
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
Quality of life by questionnaire Short Form Survey SF-36 [3 months]
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
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF) [Baseline]
Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF) [20 days]
Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF) [3 months]
Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Quality of life by questionnaire EQ-5D [Baseline]
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Quality of life by questionnaire EQ-5D [20 days]
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Quality of life by questionnaire EQ-5D [3 months]
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Quality of life by questionnaire Quality of Life: Cardiac Index [Baseline]
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
Quality of life by questionnaire Quality of Life: Cardiac Index [20 days]
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
Quality of life by questionnaire Quality of Life: Cardiac Index [3 months]
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.