Effects of Postural Balance Exercises in Patients With Heart Failure

May 29, 2022 updated by: Habibedurdu, Giresun University

Investigation of Effects of Core Stabilization and Computerized Wobble Board Exercise Training Programs in Patients With Heart Failure

In this study, the effects of core stabilization and computerized wobble board exercise training programs on postural balance and functional exercise capacity in patients over 60 years of age with heart failure will be investigated.

Study Overview

Status

Status

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

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.

Detailed Description

This study will consist of core stabilization group (CSG), wobble board group (WBG) and control group. In CSG, exercises that focus basically on the abdominal, pelvic floor, trunk extensor and diaphragm muscles and comply with core stabilization criteria will be applied. In WBG, balance exercises which focus primarily lower limb and trunk muscles, will be performed on computerized wobble board with visual feed-back provided by computerized wobble board. In control group, no exercise will be performed, only the evaluation procedure will be applied at the beginning and 8 weeks later. It was planned to include in total of 36 patients and will be randomized them into three groups with 12 patients. Following the initial assessment, each patient will participate in a one-session patient education program. After that, patients in CSG and WBG will participate in their exercise training program which supervised by physiotherapist, 3 days a week for 8 weeks.When the exercise training programs for 8 weeks were completed, initial evaluations will be re-applied. Collected data will be analyzed with SPSS 22.0 (IBM Corp., Armonk, NY, USA) program. The differences between pre- and post-treatment evaluations will be analyzed with "paired t test" and/ or " wilcoxon test".The differences between three groups will be analyzed with one-way analysis of variance and/ or Kruskal-Wallis test.

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 (Anticipated)

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.
36

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Giresun, Turkey
        • Recruiting
        • Giresun University

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 60 years and older
  • Patients with heart failure who diagnosed by cardiologist
  • Patients have stable drug therapy and to be clinically stable at least last three months
  • Patients who signed the informed consent form

Exclusion Criteria:

  • History of myocardial infarction in the last 6 months
  • Acute coronary syndrome
  • Un-controlled diabetes and/ or hypertension
  • Severe valvular heart disease and/ or arrhythmia
  • Having a pacemaker
  • Severe cognitive disorder
  • Severe orthopedic and/ or neurological problem
  • Visual or auditory impairment
  • Walking with device

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 Assignment
  • Masking: Double

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.
Experimental: Core stabilization group (CSG)
This arm consists core stabilization exercises including abdominal hallowing, supine bride, bride dog, side plank, curl-up and modified push up exercise. Each session is going to begin with warm-up training which consist of stretching exercise for upper-limb, lower-limb and trunk muscles, and complete with cool down exercise (same with warm-up training). Patients are going to attend one session of patient education before the first session.
Behavioral: Core stabilization group(CSG)
Exercises training of this group occurs from 3 stages. In the stage 1 covering the first two weeks, core stabilization exercises are going to be applied 3 sets of 10 repetitions except side plank. Side plank is going to be performed 3 sets of 10 seconds. Stage 2 is going to include from 3 to 5 weeks. In this stage, exercises are going to be performed 3 sets of 12 repetitions except bride dog, plank and side plank. These exercises are going to be applied 3 sets of 15 seconds. Patients are going to perform exercises of stage 3 from 6 to 8 weeks. Exercises of stage 3 are going to be practiced 3 sets of 15 repetitions except bride dog, side plank and plank exercises which are going to be applied 3 set of 20 second. All stages include the same exercises except modified push-up exercise includes instead of plank exercise in stage 1. All of the exercises are going to practiced 3 days a week for 8 weeks. One of the sessions is estimated to take approximately 45-60 minutes.
Experimental: Wobble board group ( WBG)
This arm consists balance training exercises which performed on computerized wobble board for primarily lower limb and anti- gravity muscle. Each session is going to begin with warm-up training which consist of stretching exercise for upper-limb, lower-limb and trunk muscles, and complete with cool down exercise (same with warm-up training). Patients are going to attend one session of patient education before the first session.
Behavioral: Wobble board group (WBG)
Patients in this group are going to perform exercise on computerized wobble board. This device is going to provide unstable surface to patient and offer visual feedback about their movement qualities. The 8 weeks program consists of 3 stages and each stage includes six exercises. In the first stage covering the first two weeks, repetitive exercises are going to be practiced 3 sets of 10 repetitions; time controlled exercises are going to be practiced 3 sets of 20 seconds. Stage 2 is going to include from 3 to 5 weeks. In this stage, repetitive exercises are going to be performed 3 sets of 12 repetition and time controlled exercises are going to be performed 3 sets of 25 seconds. Stage 3 is going to last from 6 to 8 weeks. In this stage, repetitive exercises are going to be practiced 3 sets of 15 repetitions and time controlled exercises are going to be practiced 3 sets of 30 seconds. One of the sessions is estimated to take approximately 45-60 minutes.
No Intervention: Control group (CG)
This arm was planned as a control group. Therefore, any intervention will not be performed. Patients in this arm going to participate only one session of patient education at the beginning of the program

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
Functional balance assessment
Time Frame: 8 weeks
Functional balance is going to evaluate with "berg balance scale". The scale consists of 14 items including sitting, standing up and standing up on one foot positions.Each item is scored between "0(unable)" to "4(independent) " according to success of participant. Total score is obtained by summing the scores of all items. Maximum score is 56. Scores of 0 to 20 represent balance impairment, 21 to 40 represent acceptable balance, and 41 to 56 represent good balance
8 weeks
Postural swing assessment
Time Frame: 8 weeks
Postural swing will have been assessed using with computerized wobble board. The participant's swings on the device are measured in the antreroposterior and mediolateral directions. Measurements are performed by the device including accelerometer which has 10 degrees of tilt angle.
8 weeks
Functional exercise capacity assessment
Time Frame: 8 weeks
Six minute walk test( 6MWT) will be applied. The test evaluates six minute walking distance in meters accordance with ATS/ ERS statements.
8 weeks

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
Core stabilization assessment
Time Frame: 8 weeks
"OctoCore application" is going to be used for core stabilization assessment. The application consists of two phase. The first phase is performed with single left deadline test and bird- dog exercise test is applied in second phase. Measurement of the acceleration during tests will be performed by using smart phone which has "OctoCore application" putting on mid-line of participant's fourth lumbar vertebra.
8 weeks
Health-related quality of life
Time Frame: 8 weeks
Minnesota Living with Heart Failure questionnaire will be utilized for evaluation. The questionnaire consists of 21 items and two sub-dimension. The sub-dimensions are as follows; physical and emotional. Each item is scored between "0 (no)" to "5 (too much)". Total score changes betwen 0 and 105. Lower point demonstrates good quality of life.
8 weeks

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.
Giresun University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University - Cerrahpasa (IUC)

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: Habibe DURDU, MSc, Giresun University
  • Study Director: Rengin Demir, Prof, Istanbul University - Cerrahpasa (IUC)

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.
November 15, 2021

Primary Completion (Anticipated)

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.
October 31, 2022

Study Completion (Anticipated)

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.
December 30, 2022

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).
June 2, 2021

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.
June 16, 2021

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.
June 24, 2021

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.
June 1, 2022

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.
May 29, 2022

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.
May 1, 2022

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.
  • Wobble board

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The datasets to be collected, will be available from the corresponding author on reasonable request.

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.

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