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Effects of Postural Balance Exercises in Patients With Heart Failure

Primary Purpose

Heart Failure, Systolic Heart Failure, Diastolic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Core stabilization group(CSG)
Wobble board group (WBG)
Sponsored by
Giresun University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring wobble board, core stabilization, balance training, functionally capacity, heart failure

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Giresun University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Core stabilization group (CSG)

Wobble board group ( WBG)

Control group (CG)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Functional balance assessment
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
Postural swing assessment
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.
Functional exercise capacity assessment
Six minute walk test( 6MWT) will be applied. The test evaluates six minute walking distance in meters accordance with ATS/ ERS statements.

Secondary Outcome Measures

Core stabilization assessment
"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.
Health-related quality of life
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.

Full Information

First Posted
June 2, 2021
Last Updated
January 30, 2023
Sponsor
Giresun University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04937790
Brief Title
Effects of Postural Balance Exercises in Patients With Heart Failure
Official Title
Investigation of Effects of Core Stabilization and Computerized Wobble Board Exercise Training Programs in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Giresun University
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic Heart Failure, Diastolic Heart Failure
Keywords
wobble board, core stabilization, balance training, functionally capacity, heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is 3 armed randomized controlled trial. Two groups will be participated exercise training, any intervention will not be applied to one group
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Core stabilization group (CSG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Wobble board group ( WBG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (CG)
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Core stabilization group(CSG)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wobble board group (WBG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional balance assessment
Description
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
Time Frame
8 weeks
Title
Postural swing assessment
Description
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.
Time Frame
8 weeks
Title
Functional exercise capacity assessment
Description
Six minute walk test( 6MWT) will be applied. The test evaluates six minute walking distance in meters accordance with ATS/ ERS statements.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Core stabilization assessment
Description
"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.
Time Frame
8 weeks
Title
Health-related quality of life
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Habibe DURDU, MSc
Organizational Affiliation
Giresun University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rengin DEMIR, Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Giresun University
City
Giresun
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The datasets to be collected, will be available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
32434700
Citation
Tanriverdi A, Kahraman BO, Ozsoy I, Acar S, Senturk B, Ozpelit E, Akdeniz B, Savci S. Balance performance in patients with heart failure. Heart Lung. 2020 Sep-Oct;49(5):458-462. doi: 10.1016/j.hrtlng.2020.04.004. Epub 2020 May 18.
Results Reference
result
PubMed Identifier
31273863
Citation
Piraua ALT, Cavalcante BR, de Oliveira VMA, Beltrao NB, de Amorim Batista G, Pitangui ACR, Behm D, de Araujo RC. Effect of 24-week strength training on unstable surfaces on mobility, balance, and concern about falling in older adults. Scand J Med Sci Sports. 2019 Nov;29(11):1805-1812. doi: 10.1111/sms.13510. Epub 2019 Jul 26.
Results Reference
result
PubMed Identifier
23108436
Citation
Granacher U, Lacroix A, Muehlbauer T, Roettger K, Gollhofer A. Effects of core instability strength training on trunk muscle strength, spinal mobility, dynamic balance and functional mobility in older adults. Gerontology. 2013;59(2):105-13. doi: 10.1159/000343152. Epub 2012 Oct 24.
Results Reference
result
PubMed Identifier
21869636
Citation
Ogaya S, Ikezoe T, Soda N, Ichihashi N. Effects of balance training using wobble boards in the elderly. J Strength Cond Res. 2011 Sep;25(9):2616-22. doi: 10.1519/JSC.0b013e31820019cf.
Results Reference
result

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Effects of Postural Balance Exercises in Patients With Heart Failure

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