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

NCT04234087 | Completed

• 1 other identifier: LUHS001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiac rehabilitation; Exercise training; Resistance training; Balance training; Physical capacity; Valve surgery; Valve intervention; Functional capacity

Outcome Measures

Primary Outcomes (21)

• Physical performance by Short Physical Perfromance Battery (SPPB)

  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).

  Baseline

• Physical performance by Short Physical Perfromance Battery (SPPB)

  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).

  20 days

• Physical performance by Short Physical Perfromance Battery (SPPB)

  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).

  Three months

• Physical performance by 5 meters walking test (5MWT)

  5MWT is a gate speed test measured by meters per second.

  Baseline

• Physical performance by 5 meters walking test (5MWT)

  5MWT is a gate speed test measured by meters per second.

  20 days

• Physical performance by 5 meters walking test (5MWT)

  5MWT is a gate speed test measured by meters per second.

  3 months

• Functional capacity by six minutes walking test (6MWT)

  6MWT measured by meters

  Baseline

• Functional capacity by six minutes walking test (6MWT)

  6MWT measured by meters

  20 days

• Functional capacity by six minutes walking test (6MWT)

  6MWT measured by meters

  3 months

• Quality of life by questionnaire Short Form Survey SF-36

  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

  Baseline

• Quality of life by questionnaire Short Form Survey SF-36

  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

  20 days

• Quality of life by questionnaire Short Form Survey SF-36

  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

  3 months

• Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)

  Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life

  Baseline

• Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)

  Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life

  20 days

• Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)

  Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life

  3 months

• Quality of life by questionnaire EQ-5D

  EQ-5D in units on the scale, 0-10, the higher score, the better quality of life

  Baseline

• Quality of life by questionnaire EQ-5D

  EQ-5D in units on the scale, 0-10, the higher score, the better quality of life

  20 days

• Quality of life by questionnaire EQ-5D

  EQ-5D in units on the scale, 0-10, the higher score, the better quality of life

  3 months

• Quality of life by questionnaire Quality of Life: Cardiac Index

  Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life

  Baseline

• Quality of life by questionnaire Quality of Life: Cardiac Index

  Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life

  20 days

• Quality of life by questionnaire Quality of Life: Cardiac Index

  Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life

  3 months

Secondary Outcomes (18)

• Frailty level by SPPB score

  baseline

• Frailty level by SPPB score

  20 days

• Frailty level by SPPB score

  three months

• Frailty level by 5MWT

  baseline

• Frailty level by 5MWT

  20 days

Study Arms (2)

Control group

NO INTERVENTION

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

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.

Other: Additional balance and resistance training

Interventions

Additional balance and resistance training 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.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients after valve surgery and/or intervention
• Age 65 years and older
• Ability to start CR within 4 weeks after surgery,
• minute walk distance (6-MWD) ≥100- ≤350 m (1)
• Patient's agreement to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Kaunas, Kulautuva, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 33413144 DERIVED

MeSH Terms

Conditions

Frailty; Heart Valve Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Raimondas Kubilius, Prof

  Lithuanian University of Health Sciences, Department of Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of a Rehabilitation department

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 21, 2020
• Study Start: February 26, 2018
• Primary Completion: February 1, 2020
• Study Completion: June 30, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)