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

Heart Failure,Balance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853759
• Other study ID #: GO 18/736-06
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: January 17, 2020

Study information

• Verified date: February 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 17, 2020
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Balance

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Physiotherapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance Assesment	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.	1st Day
Primary	Gait Parameters	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.	1st Day
Secondary	Cognition	Cognition Using Mini Mental State Examination Test (MMSE) Cognitive function will be evaluated the screening tool the Mini Mental State Examination (MMSE)	1st Day
Secondary	Exercise Capacity	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.	1st Day
Secondary	Muscle Strength	Muscle Strength assesment M.Quadriceps Femoris muscles strength will be evaluated non-invasive methods by measuring muscle dynamometer device. Both legs will be measured.	1st Day
Secondary	Level of Physical Activity	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	1st Day
Secondary	Balance Confidence	Balance Confidence Using Activity Specific Balance Confidence Scale (ABC) This scale contains 16 tasks related to indoor and outdoor daily living activities	1st Day