Clinical trial NCT04234087: Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention
Official title: Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty Syndrome
Quality of Life
Valve Heart Disease
Keywords: Cardiac rehabilitation
Exercise training
Resistance training
Balance training
Physical capacity
Valve surgery
Valve intervention
Functional capacity
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 116
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Physical performance by Short Physical Perfromance Battery (SPPB)
timeFrame: Baseline
measure: Physical performance by Short Physical Perfromance Battery (SPPB)
timeFrame: 20 days
measure: Physical performance by Short Physical Perfromance Battery (SPPB)
timeFrame: Three months
measure: Physical performance by 5 meters walking test (5MWT)
timeFrame: Baseline
measure: Physical performance by 5 meters walking test (5MWT)
timeFrame: 20 days
measure: Physical performance by 5 meters walking test (5MWT)
timeFrame: 3 months
measure: Functional capacity by six minutes walking test (6MWT)
timeFrame: Baseline
measure: Functional capacity by six minutes walking test (6MWT)
timeFrame: 20 days
measure: Functional capacity by six minutes walking test (6MWT)
timeFrame: 3 months
measure: Quality of life by questionnaire Short Form Survey SF-36
timeFrame: Baseline
measure: Quality of life by questionnaire Short Form Survey SF-36
timeFrame: 20 days
measure: Quality of life by questionnaire Short Form Survey SF-36
timeFrame: 3 months
measure: Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)
timeFrame: Baseline
measure: Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)
timeFrame: 20 days
measure: Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)
timeFrame: 3 months
measure: Quality of life by questionnaire EQ-5D
timeFrame: Baseline
measure: Quality of life by questionnaire EQ-5D
timeFrame: 20 days
measure: Quality of life by questionnaire EQ-5D
timeFrame: 3 months
measure: Quality of life by questionnaire Quality of Life: Cardiac Index
timeFrame: Baseline
measure: Quality of life by questionnaire Quality of Life: Cardiac Index
timeFrame: 20 days
measure: Quality of life by questionnaire Quality of Life: Cardiac Index
timeFrame: 3 months
Secondary outcomes:
measure: Frailty level by SPPB score
timeFrame: baseline
measure: Frailty level by SPPB score
timeFrame: 20 days
measure: Frailty level by SPPB score
timeFrame: three months
measure: Frailty level by 5MWT
timeFrame: baseline
measure: Frailty level by 5MWT
timeFrame: 20 days
measure: Frailty level by 5MWT
timeFrame: three months
measure: Physical activity by International physical activity questionnaire (IPAQ)
timeFrame: 3 months
measure: Physical activity by International physical activity questionnaire (IPAQ)
timeFrame: 20 days
measure: Physical activity by International physical activity questionnaire (IPAQ)
timeFrame: Baseline
measure: Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
timeFrame: Baseline
measure: Cardiopulmonary exercise capacity by maximal load (maxWatt)
timeFrame: Baseline
measure: Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
timeFrame: 20 days
measure: Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
timeFrame: 3 months
measure: Cardiopulmonary exercise capacity by maximal load (maxWatt)
timeFrame: 20 days
measure: Cardiopulmonary exercise capacity by maximal load (maxWatt)
timeFrame: 3 months
measure: Muscular strength by one repetition maximum test (1RM)
timeFrame: baseline
measure: Muscular strength by one repetition maximum test (1RM)
timeFrame: 20 days
measure: Muscular strength by one repetition maximum test (1RM)
timeFrame: 3 months
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
state: Kulautuva
Study officials:
affiliation: Lithuanian University of Health Sciences, Department of Rehabilitation
name: Raimondas Kubilius, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.