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

NCT ID: NCT04234087

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-26
• Study Completion Date: 2020-06-30

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.

Conditions

Frailty Syndrome; Quality of Life; Valve Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type: OTHER

Additional balance and resistance training

Intervention Type: OTHER

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.

Interventions

Additional 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Eglė Tamulevičiūtė-Prascienė

Head of a Rehabilitation department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raimondas Kubilius, Prof

Role: PRINCIPAL_INVESTIGATOR

Lithuanian University of Health Sciences, Department of Rehabilitation

Locations

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Kaunas, Kulautuva, Lithuania

Countries

Lithuania

References

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.

Reference Type: DERIVED

PMID: 33413144 (View on PubMed)

Other Identifiers

LUHS001

Identifier Type: -

Identifier Source: org_study_id