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

Study Overview
=================
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.

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

Conditions
-----------------
Frailty Syndrome, Quality of Life, Valve Heart Disease

Intervention / Treatment
-----------------
* Other: Additional balance and resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac rehabilitation, Exercise training, Resistance training, Balance training, Physical capacity, Valve surgery, Valve intervention, Functional capacity