Effects of Postural Balance Exercises in Patients With Heart Failure

NCT ID: NCT04937790

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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Heart Failure Systolic Heart Failure Diastolic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is 3 armed randomized controlled trial. Two groups will be participated exercise training, any intervention will not be applied to one group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Core stabilization group(CSG)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Wobble board group (WBG)

Intervention Type BEHAVIORAL

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Giresun University

OTHER

Sponsor Role lead

Responsible Party

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Habibedurdu

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Habibe DURDU, MSc

Role: PRINCIPAL_INVESTIGATOR

Giresun University

Rengin DEMIR, Prof

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

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Giresun University

Giresun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 32434700 (View on PubMed)

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.

Reference Type RESULT
PMID: 31273863 (View on PubMed)

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.

Reference Type RESULT
PMID: 23108436 (View on PubMed)

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.

Reference Type RESULT
PMID: 21869636 (View on PubMed)

Durdu H, Demir R, Zeren M, Aydin E, Gunaydin ZY, Yigit Z. The Effect of Computerized Wobble Board and Core Stabilization Exercises on Balance Performance and Exercise Capacity in Patients With Heart Failure: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Aug;105(8):1429-1438. doi: 10.1016/j.apmr.2024.04.003. Epub 2024 Apr 12.

Reference Type DERIVED
PMID: 38614379 (View on PubMed)

Other Identifiers

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Wobble board

Identifier Type: -

Identifier Source: org_study_id

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