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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04234087
Enrollment
116
Registered
2020-01-21
Start date
2018-02-26
Completion date
2020-06-30
Last updated
2020-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERAdditional 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.

Sponsors

Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of life by questionnaire Quality of Life: Cardiac IndexBaselineQuality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
Physical performance by Short Physical Perfromance Battery (SPPB)BaselineThe 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)Baseline5MWT is a gate speed test measured by meters per second.
Functional capacity by six minutes walking test (6MWT)Baseline6MWT measured by meters
Quality of life by questionnaire Short Form Survey SF-36Baseline0-100%, 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)BaselineMinesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Quality of life by questionnaire EQ-5DBaselineEQ-5D in units on the scale, 0-10, the higher score, the better quality of life

Secondary

MeasureTime frameDescription
Frailty level by 5MWTbaselineFrailty 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 monthsIPAQ in units on the scale
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)BaselinePeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Cardiopulmonary exercise capacity by maximal load (maxWatt)BaselineMaximal load measured with spiroergometry by maximal watts
Muscular strength by one repetition maximum test (1RM)baseline1RM test for leg extension measured by kilograms
Frailty level by SPPB scorebaselineFrailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026