Heart Failure,BalanceNCT03853759
COMPARİSON OF HEART FAİLURE PATİENTS AND HEALTHY PEOPLE İN BALANCE AND GAİT PARAMETERS
An observational study of Heart Failure,Balance, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to show the difference between balance and gait parameters in heart failure and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure,Balance
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 17 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physiotherapy and Rehabilitation
Ankara
About this study
We aimed to show the difference between balance and gait parameters in heart failure and healthy individuals.
Read the 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.
- Conditions
- Heart Failure,Balance
- Keywords
- Gait Parameters, Heart Failure,Balance,Gait,Cognition,Functional Capacity,Muscle Strength
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Heart Failure | Not described | |
| Healthy İndividuals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st Day
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.
Measured: 1st Day
Secondary outcomes (5)
Cognition
Cognition Using Mini Mental State Examination Test (MMSE) Cognitive function will be evaluated the screening tool the Mini Mental State Examination (MMSE)
Measured: 1st Day
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.
Measured: 1st Day
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.
Measured: 1st Day
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
Measured: 1st Day
Balance Confidence
Balance Confidence Using Activity Specific Balance Confidence Scale (ABC) This scale contains 16 tasks related to indoor and outdoor daily living activities
Measured: 1st Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Sep 2018
- Primary completion17 Dec 2019
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure,BalanceStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.Burcu ÖZCAN, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853759
- Sponsor's protocol ID
- GO 18/736-06
- Status last verified
- Feb 2020
- First submitted
- 22 Feb 2019
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARİSON OF HEART FAİLURE PATİENTS AND HEALTHY PEOPLE İN BALANCE AND GAİT PARAMETERS
- ClinicalTrials.gov ID
- NCT03853759
- Acronym / sponsor ID
- GO 18/736-06
- Conditions
- Heart Failure,Balance
- Keywords
- Gait Parameters, Heart Failure,Balance,Gait,Cognition,Functional Capacity,Muscle Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Heart Failure | – | – |
| Healthy İndividuals | – | – |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
5 secondary outcomes
Cognition
Time frame: 1st Day
Exercise Capacity
Time frame: 1st Day
Muscle Strength
Time frame: 1st Day
Level of Physical Activity
Time frame: 1st Day
Balance Confidence
Time frame: 1st Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure,Balance, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Assesment (time frame: 1st Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.