Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention
- Conditions
- Quality of LifeFrailty SyndromeValve Heart Disease
- Interventions
- Other: Additional balance and resistance training
- Registration Number
- NCT04234087
- Lead Sponsor
- Lithuanian University of Health Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Additional balance and resistance training 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.
- Primary Outcome Measures
Name Time Method Functional capacity by six minutes walking test (6MWT) 3 months 6MWT measured by meters
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).
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) 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 3 months EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Physical performance by 5 meters walking test (5MWT) 3 months 5MWT is a gate speed test measured by meters per second.
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
Name Time Method Frailty level by SPPB score three months Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
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
Muscular strength by one repetition maximum test (1RM) 3 months 1RM test for leg extension measured by kilograms
Cardiopulmonary exercise capacity by maximal load (maxWatt) 3 months Maximal load measured with spiroergometry by maximal watts
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) Baseline IPAQ in units on the scale
Trial Locations
- Locations (1)
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
🇱🇹Kaunas, Kulautuva, Lithuania