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

Lithuanian University of Health Sciences

Status: Completed

Conditions: Quality of Life; Valve Heart Disease; Frailty Syndrome

Treatments: Other: Additional balance and resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT04234087

LUHS001

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

116 participants in 2 patient groups

Control group

No Intervention group

Description:

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.

Intervention group

Other group

Description:

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.

Treatment:

Other: Additional balance and resistance training