COMPARİSON OF HEART FAİLURE PATİENTS AND HEALTHY PEOPLE İN BALANCE AND GAİT PARAMETERS

Completed

• Conditions: Heart Failure,Balance

• Registration Number: NCT03853759
• Lead Sponsor: Hacettepe University

Brief Summary

We aimed to show the difference between balance and gait parameters in heart failure and healthy individuals.

Detailed Description

Heart failure is the inability of the heart to pump a sufficient amount of blood into our body. The reason is usually the decrease in the contractile capacity of myocardium due to decreased coronary blood flow. Symptoms and symptoms may be quite diverse in the underlying pathophysiology of heart failure, which is usually the only type. As a result of heart failure; problems such as dyspnoea, anemia, peripheral edema, peripheral muscle involvement and decreased muscle mass, confusion, sleep disorder, dementia, various cardiac symptoms and renal failure can be seen.

Balance body with minimal muscle activity in static or dynamic position on the support base is to maintain the center of gravity. Patients with heart failure may have decreased postural control, exercise intolerance, breathing problems, and decreased cognitive function.

Gait analysis, evaluation of neuro musculoskeletal system functions and interpretation of results with numbers and graphs. Gait analysis is an analysis method that plays a role in many cases of clinical diagnosis and follow-up. Heart failure is characterized by a significant reduction in walking distance, which leads to reduced quality of life. In a study conducted in heart failure, it is stated that gait velocity is a determinant of one year mortality and hospitalization, and should be considered for clinical evaluations and prognosis. All these causes of heart failure in chronic disease groups defined considering it is important to investigate the balance and gait parameters.

This study will show the difference between the balance and walking parameters in heart failure according to the healthy participants.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-02-22
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-26
• Primary Completion: 2019-12-17
• Study Completion: 2020-01-17
• Status Verified: 2020-02
• Last Update Submitted: 2022-07-09
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Ejection fraction <40% or less,
• Without acute decompensation,
• No revascularization in the last six months,
• The drug has been stable for the last four weeks,
• Accepts participation in the study,
• Coopere,
• NewYork Heart Association -NYHA Class II- III
• Patients with heart failure who are amputated without support or assistive devices will be included in the study.

Exclusion Criteria

• Neurological, cognitive or orthopedic diseases that affect the measurements,
• Severe respiratory disease (FEV1 <35%),
• BNP> 100pg / ml and above,
• Acute infection,
• Resting heart rate above 140 beats / min,
• Dementia,
• Having a BMI> 35 or above,
• Individuals with other chronic diseases that may affect their balance and walking will not be included in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Balance Assesment	1st Day	Balance Assesment will be evaluated with Mini-Balance Evaluation Systems Test (Mini-BESTest) The Mini-BESTest includes four subscales: transitions/anticipatory postural control, reactive postural control, sensory orientation and stability in gait. Each item is rated on a three-point ordinal scale (0 = severe to 2 = normal). t the MiniBESTest consists of 14 items, with a maximum score of 28 points. The Mini-BESTest takes 10 to 15 minutes to administer.
Gait Parameters	1st Day	Gait Parameters assesment using Biodex Gait Trainer It will be evaluated from the basic walking parameters in terms of walking speed, double step length, number of steps per minute, step cycle and ambulation index.

Secondary Outcome Measures

Name	Time	Method
Muscle Strength	1st Day	Muscle Strength assesment M.Quadriceps Femoris muscles strength will be evaluated non-invasive methods by measuring muscle dynamometer device. Both legs will be measured.
Cognition	1st Day	Cognition Using Mini Mental State Examination Test (MMSE) Cognitive function will be evaluated the screening tool the Mini Mental State Examination (MMSE)
Exercise Capacity	1st Day	Exercise Capacity Using 6-Minute Walk Test The standard protocol of the test is applied in a 30 meter continuous corridor.Standard instructions are given during testing.
Balance Confidence	1st Day	Balance Confidence Using Activity Specific Balance Confidence Scale (ABC) This scale contains 16 tasks related to indoor and outdoor daily living activities
Level of Physical Activity	1st Day	Level of Physical Activity Assesment Using The International Physical Activity Questionnaires (IPAQ) The questionnaire consists of seven questions and provides information on the time spent in walking, mid-severe activities

Trial Locations

Locations (1)

Hacettepe University Faculty of Physiotherapy and Rehabilitation; 🇹🇷 Ankara, Turkey