Clinical trial NCT04937790: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Systolic Heart Failure
Diastolic Heart Failure
Keywords: wobble board
core stabilization
balance training
functionally capacity
heart failure
Lead sponsor: Giresun University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2021-06-24
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional balance assessment
timeFrame: 8 weeks
measure: Postural swing assessment
timeFrame: 8 weeks
measure: Functional exercise capacity assessment
timeFrame: 8 weeks
Secondary outcomes:
measure: Core stabilization assessment
timeFrame: 8 weeks
measure: Health-related quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University
Study officials:
affiliation: Giresun University
name: Habibe DURDU, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Rengin DEMIR, Prof
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.