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

July 14, 2020 updated by: Eglė Tamulevičiūtė-Prascienė, Lithuanian University of Health Sciences
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
    • Kulautuva
      • Kaunas, Kulautuva, Lithuania
        • LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: 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.
OTHER: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical performance by Short Physical Perfromance Battery (SPPB)
Time Frame: Baseline
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)
Time Frame: 20 days
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)
Time Frame: Three months
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)
Time Frame: Baseline
5MWT is a gate speed test measured by meters per second.
Baseline
Physical performance by 5 meters walking test (5MWT)
Time Frame: 20 days
5MWT is a gate speed test measured by meters per second.
20 days
Physical performance by 5 meters walking test (5MWT)
Time Frame: 3 months
5MWT is a gate speed test measured by meters per second.
3 months
Functional capacity by six minutes walking test (6MWT)
Time Frame: Baseline
6MWT measured by meters
Baseline
Functional capacity by six minutes walking test (6MWT)
Time Frame: 20 days
6MWT measured by meters
20 days
Functional capacity by six minutes walking test (6MWT)
Time Frame: 3 months
6MWT measured by meters
3 months
Quality of life by questionnaire Short Form Survey SF-36
Time Frame: Baseline
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
Time Frame: 20 days
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
Time Frame: 3 months
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)
Time Frame: Baseline
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)
Time Frame: 20 days
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)
Time Frame: 3 months
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
Time Frame: Baseline
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
Time Frame: 20 days
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
Time Frame: 3 months
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
Time Frame: Baseline
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
Time Frame: 20 days
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
Time Frame: 3 months
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frailty level by SPPB score
Time Frame: baseline
Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
baseline
Frailty level by SPPB score
Time Frame: 20 days
Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
20 days
Frailty level by SPPB score
Time Frame: three months
Frailty measured by SPPB score - 0-7 - frail, 8-9 - pre-frail, 10-12 robust.
three months
Frailty level by 5MWT
Time Frame: baseline
Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust
baseline
Frailty level by 5MWT
Time Frame: 20 days
Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust
20 days
Frailty level by 5MWT
Time Frame: three months
Frailty measured by 5MWT - <0,6 m/s - frail, 0,7-0,99 m/s - pre-frail, 1,0 m/s and more - robust
three months
Physical activity by International physical activity questionnaire (IPAQ)
Time Frame: 3 months
IPAQ in units on the scale
3 months
Physical activity by International physical activity questionnaire (IPAQ)
Time Frame: 20 days
IPAQ in units on the scale
20 days
Physical activity by International physical activity questionnaire (IPAQ)
Time Frame: Baseline
IPAQ in units on the scale
Baseline
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Time Frame: Baseline
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
Baseline
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Time Frame: Baseline
Maximal load measured with spiroergometry by maximal watts
Baseline
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Time Frame: 20 days
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
20 days
Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
Time Frame: 3 months
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
3 months
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Time Frame: 20 days
Maximal load measured with spiroergometry by maximal watts
20 days
Cardiopulmonary exercise capacity by maximal load (maxWatt)
Time Frame: 3 months
Maximal load measured with spiroergometry by maximal watts
3 months
Muscular strength by one repetition maximum test (1RM)
Time Frame: baseline
1RM test for leg extension measured by kilograms
baseline
Muscular strength by one repetition maximum test (1RM)
Time Frame: 20 days
1RM test for leg extension measured by kilograms
20 days
Muscular strength by one repetition maximum test (1RM)
Time Frame: 3 months
1RM test for leg extension measured by kilograms
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lithuanian University of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raimondas Kubilius, Prof, Lithuanian University of Health Sciences, Department of Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LUHS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings