Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.


The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03853759
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2019
Last Update Posted : February 28, 2019
Information provided by (Responsible Party):
E.Burcu ÖZCAN, Hacettepe University

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

Condition or disease
Heart Failure,Balance

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 38 participants
Observational Model: Case-Control
Time Perspective: Prospective
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 17, 2020
Estimated Study Completion Date : June 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Patients with Heart Failure
Healthy İndividuals

Primary Outcome Measures :
  1. Balance Assesment [ Time Frame: 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.

  2. Gait Parameters [ Time Frame: 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 :
  1. Cognition [ Time Frame: 1st Day ]
    Cognition Using Mini Mental State Examination Test (MMSE) Cognitive function will be evaluated the screening tool the Mini Mental State Examination (MMSE)

  2. Exercise Capacity [ Time Frame: 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.

  3. Muscle Strength [ Time Frame: 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.

  4. Level of Physical Activity [ Time Frame: 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

  5. Balance Confidence [ Time Frame: 1st Day ]
    Balance Confidence Using Activity Specific Balance Confidence Scale (ABC) This scale contains 16 tasks related to indoor and outdoor daily living activities

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
İndividuals who are diagnosed with Heart Failure at Hacettepe University and who reffered to the Cardiopulmonary Rehabilitation Unit for Physiotherapy also who are willing to participate in the study will be include in the study.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03853759

Layout table for location information
Hacettepe University Faculty of Physiotherapy and Rehabilitation
Ankara, Turkey
Sponsors and Collaborators
Hacettepe University

Layout table for additonal information
Other Study ID Numbers: GO 18/736-06
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by E.Burcu ÖZCAN, Hacettepe University:
Gait Parameters, Heart Failure,Balance,Gait,Cognition,Functional Capacity,Muscle Strength
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases