Effects of Postural Balance Exercises in Patients With Heart Failure

Sponsor
Giresun University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04937790
Collaborator
Istanbul University-Cerrahpasa (Other)
36
1
3
13.5
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Core stabilization group(CSG)
  • Behavioral: Wobble board group (WBG)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 groupThis study is 3 armed randomized controlled trial. Two groups will be participated exercise training, any intervention will not be applied to one group
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Investigation of Effects of Core Stabilization and Computerized Wobble Board Exercise Training Programs in Patients With Heart Failure
Actual Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Functional balance assessment [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

  2. Postural swing assessment [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.

  3. Functional exercise capacity assessment [8 weeks]

    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

  1. Core stabilization assessment [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.

  2. Health-related quality of life [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Giresun University Giresun Turkey

Sponsors and Collaborators

  • Giresun University
  • Istanbul University-Cerrahpasa

Investigators

  • Principal Investigator: Habibe DURDU, MSc, Giresun University
  • Study Director: Rengin DEMIR, Prof, Istanbul University - Cerrahpaşa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Habibedurdu, Lecturer, Giresun University
ClinicalTrials.gov Identifier:
NCT04937790
Other Study ID Numbers:
  • Wobble board
First Posted:
Jun 24, 2021
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Habibedurdu, Lecturer, Giresun University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022