Effects of Postural Balance Exercises in Patients With Heart Failure

NCT04937790 | Completed

• 1 other identifier: Wobble board
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Systolic Heart Failure; Diastolic Heart Failure

Keywords

wobble board; core stabilization; balance training; functionally capacity; heart failure

Outcome Measures

Primary Outcomes (3)

• 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

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

Secondary Outcomes (2)

• Core stabilization assessment

  8 weeks

• Health-related quality of life

  8 weeks

Study Arms (3)

Core stabilization group (CSG)

EXPERIMENTAL

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)

Wobble board group ( WBG)

EXPERIMENTAL

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)

Control group (CG)

NO INTERVENTION

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

Interventions

Core stabilization group(CSG) 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.

Core stabilization group (CSG)

Wobble board group (WBG) 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.

Wobble board group ( WBG)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Giresun University

Giresun, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 32434700 RESULT

• 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.

  PMID: 31273863 RESULT

• 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.

  PMID: 23108436 RESULT

• 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.

  PMID: 21869636 RESULT

• 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.

  PMID: 38614379 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Habibe DURDU, MSc

  Giresun University

  PRINCIPAL INVESTIGATOR

• Rengin DEMIR, Prof

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 24, 2021
• Study Start: June 15, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 30, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)