Effects of Postural Balance Exercises in Patients With Heart Failure

Not Applicable

Completed

• Conditions: Systolic Heart Failure; Diastolic Heart Failure; Heart Failure
• Interventions: Behavioral: Wobble board group (WBG); Behavioral: Core stabilization group(CSG)

• Registration Number: NCT04937790
• Lead Sponsor: Giresun University

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.

Study Timeline

• Study First Submitted: 2021-06-02
• Study Start: 2021-06-15
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-24
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wobble board group ( WBG)	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.
Core stabilization group (CSG)	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.

Primary Outcome Measures

Name	Time	Method
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
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.
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Giresun University; 🇹🇷 Giresun, Turkey