Heart FailureNCT04937790
Effects of Postural Balance Exercises in Patients With Heart Failure
A study testing Core stabilization group(CSG) and Wobble board group (WBG) in people with Heart Failure and Systolic Heart Failure, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure, Systolic Heart Failure, Diastolic Heart Failure
- What is being tested?
- Core stabilization group(CSG) and Wobble board group (WBG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2021to 30 Dec 2022
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Severe orthopedic and/ or neurological problem
- Visual or auditory impairment
- Walking with device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Effects of Core Stabilization and Computerized Wobble Board Exercise Training Programs in Patients With Heart Failure
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.
Read the 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.
- Being tested
- Core stabilization group(CSG), Wobble board group (WBG)
- Keywords
- wobble board, core stabilization, balance training, functionally capacity, heart failure
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization group(CSG)Behavioural
Exercises training of this group occurs from 3 stages. In the stage 1 covering the first two weeks, core stabilization exercises are going to be applied 3 sets of 10 repetitions except side plank. Side plank is going to be performed 3 sets of 10 seconds. Stage 2 is going to include from 3 to 5 weeks. In this stage, exercises are going to be performed 3 sets of 12 repetitions except bride dog, plank and side plank. These exercises are going to be applied 3 sets of 15 seconds. Patients are going to perform exercises of stage 3 from 6 to 8 weeks. Exercises of stage 3 are going to be practiced 3 sets of 15 repetitions except bride dog, side plank and plank exercises which are going to be applied 3 set of 20 second. All stages include the same exercises except modified push-up exercise includes instead of plank exercise in stage 1. All of the exercises are going to practiced 3 days a week for 8 weeks. One of the sessions is estimated to take approximately 45-60 minutes.
Wobble board group (WBG)Behavioural
Patients in this group are going to perform exercise on computerized wobble board. This device is going to provide unstable surface to patient and offer visual feedback about their movement qualities. The 8 weeks program consists of 3 stages and each stage includes six exercises. In the first stage covering the first two weeks, repetitive exercises are going to be practiced 3 sets of 10 repetitions; time controlled exercises are going to be practiced 3 sets of 20 seconds. Stage 2 is going to include from 3 to 5 weeks. In this stage, repetitive exercises are going to be performed 3 sets of 12 repetition and time controlled exercises are going to be performed 3 sets of 25 seconds. Stage 3 is going to last from 6 to 8 weeks. In this stage, repetitive exercises are going to be practiced 3 sets of 15 repetitions and time controlled exercises are going to be practiced 3 sets of 30 seconds. One of the sessions is estimated to take approximately 45-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization group (CSG) | Experimental | This arm consists core stabilization exercises including abdominal hallowing, supine bride, bride dog, side plank, curl-up and modified push up exercise. Each session is going to begin with warm-up training which consist of stretching exercise for upper-limb, lower-limb and trunk muscles, and complete with cool down exercise (same with warm-up training). Patients are going to attend one session of patient education before the first session. Receives: Behavioral: Core stabilization group(CSG) |
| Wobble board group ( WBG) | Experimental | This arm consists balance training exercises which performed on computerized wobble board for primarily lower limb and anti- gravity muscle. Each session is going to begin with warm-up training which consist of stretching exercise for upper-limb, lower-limb and trunk muscles, and complete with cool down exercise (same with warm-up training). Patients are going to attend one session of patient education before the first session. Receives: Behavioral: Wobble board group (WBG) |
| Control group (CG) | No intervention | This arm was planned as a control group. Therefore, any intervention will not be performed. Patients in this arm going to participate only one session of patient education at the beginning of the program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional balance assessment
Functional balance is going to evaluate with "berg balance scale". The scale consists of 14 items including sitting, standing up and standing up on one foot positions.Each item is scored between "0(unable)" to "4(independent) " according to success of participant. Total score is obtained by summing the scores of all items. Maximum score is 56. Scores of 0 to 20 represent balance impairment, 21 to 40 represent acceptable balance, and 41 to 56 represent good balance
Measured: 8 weeks
Postural swing assessment
Postural swing will have been assessed using with computerized wobble board. The participant's swings on the device are measured in the antreroposterior and mediolateral directions. Measurements are performed by the device including accelerometer which has 10 degrees of tilt angle.
Measured: 8 weeks
Functional exercise capacity assessment
Six minute walk test( 6MWT) will be applied. The test evaluates six minute walking distance in meters accordance with ATS/ ERS statements.
Measured: 8 weeks
Secondary outcomes (2)
Core stabilization assessment
"OctoCore application" is going to be used for core stabilization assessment. The application consists of two phase. The first phase is performed with single left deadline test and bird- dog exercise test is applied in second phase. Measurement of the acceleration during tests will be performed by using smart phone which has "OctoCore application" putting on mid-line of participant's fourth lumbar vertebra.
Measured: 8 weeks
Health-related quality of life
Minnesota Living with Heart Failure questionnaire will be utilized for evaluation. The questionnaire consists of 21 items and two sub-dimension. The sub-dimensions are as follows; physical and emotional. Each item is scored between "0 (no)" to "5 (too much)". Total score changes betwen 0 and 105. Lower point demonstrates good quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start15 Jun 2021
- Primary completion31 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Habibedurdu, Giresun University
- Investigators
- Habibe DURDU, MSc, Principal investigator, Giresun UniversityRengin DEMIR, Prof, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937790
- Sponsor's protocol ID
- Wobble board
- Status last verified
- Jan 2023
- First submitted
- 2 Jun 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets to be collected, will be available from the corresponding author on reasonable request.
Publications
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.
PubMed 32434700Piraua 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.
PubMed 31273863Granacher 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.
PubMed 23108436Ogaya 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.
PubMed 21869636Durdu H, Demir R, Zeren M, Aydin E, Gunaydin ZY, Yigit Z. The Effect of Computerized Wobble Board and Core Stabilization Exercises on Balance Performance and Exercise Capacity in Patients With Heart Failure: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Aug;105(8):1429-1438. doi: 10.1016/j.apmr.2024.04.003. Epub 2024 Apr 12.
PubMed 38614379
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effects of Core Stabilization and Computerized Wobble Board Exercise Training Programs in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04937790
- Acronym / sponsor ID
- Wobble board
- Keywords
- wobble board, core stabilization, balance training, functionally capacity, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 24 Jun 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Core stabilization group (CSG) | Experimental | Behavioral: Core stabilization group(CSG)This arm consists core stabilization exercises including abdominal hallowing, supine bride, bride dog, side plank, curl-up and modified push up exercise. Each session is going to begin with warm-up training which consist of stretching exercise for upper-limb, lower-limb and trunk muscles, and complete with cool down exercise (same with warm-up training). Patients are going to attend one session of patient education before the first session. |
| Wobble board group ( WBG) | Experimental | Behavioral: Wobble board group (WBG)This arm consists balance training exercises which performed on computerized wobble board for primarily lower limb and anti- gravity muscle. Each session is going to begin with warm-up training which consist of stretching exercise for upper-limb, lower-limb and trunk muscles, and complete with cool down exercise (same with warm-up training). Patients are going to attend one session of patient education before the first session. |
| Control group (CG) | No intervention | –This arm was planned as a control group. Therefore, any intervention will not be performed. Patients in this arm going to participate only one session of patient education at the beginning of the program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stabilization group(CSG)Exercises training of this group occurs from 3 stages. In the stage 1 covering the first two weeks, core stabilization exercises are going to be applied 3 sets of 10 repetitions except side plank. Side plank is going to be performed 3 sets of 10 seconds. Stage 2 is going to include from 3 to 5 weeks. In this stage, exercises are going to be performed 3 sets of 12 repetitions except bride dog, plank and side plank. These exercises are going to be applied 3 sets of 15 seconds. Patients are going to perform exercises of stage 3 from 6 to 8 weeks. Exercises of stage 3 are going to be practiced 3 sets of 15 repetitions except bride dog, side plank and plank exercises which are going to be applied 3 set of 20 second. All stages include the same exercises except modified push-up exercise includes instead of plank exercise in stage 1. All of the exercises are going to practiced 3 days a week for 8 weeks. One of the sessions is estimated to take approximately 45-60 minutes. | Behavioural | Core stabilization group (CSG) |
| Wobble board group (WBG)Patients in this group are going to perform exercise on computerized wobble board. This device is going to provide unstable surface to patient and offer visual feedback about their movement qualities. The 8 weeks program consists of 3 stages and each stage includes six exercises. In the first stage covering the first two weeks, repetitive exercises are going to be practiced 3 sets of 10 repetitions; time controlled exercises are going to be practiced 3 sets of 20 seconds. Stage 2 is going to include from 3 to 5 weeks. In this stage, repetitive exercises are going to be performed 3 sets of 12 repetition and time controlled exercises are going to be performed 3 sets of 25 seconds. Stage 3 is going to last from 6 to 8 weeks. In this stage, repetitive exercises are going to be practiced 3 sets of 15 repetitions and time controlled exercises are going to be practiced 3 sets of 30 seconds. One of the sessions is estimated to take approximately 45-60 minutes. | Behavioural | Wobble board group ( WBG) |
Primary outcome
Functional balance assessment
Time frame: 8 weeks
Functional balance is going to evaluate with "berg balance scale". The scale consists of 14 items including sitting, standing up and standing up on one foot positions.Each item is scored between "0(unable)" to "4(independent) " according to success of participant. Total score is obtained by summing the scores of all items. Maximum score is 56. Scores of 0 to 20 represent balance impairment, 21 to 40 represent acceptable balance, and 41 to 56 represent good balance
Postural swing assessment
Time frame: 8 weeks
Postural swing will have been assessed using with computerized wobble board. The participant's swings on the device are measured in the antreroposterior and mediolateral directions. Measurements are performed by the device including accelerometer which has 10 degrees of tilt angle.
Functional exercise capacity assessment
Time frame: 8 weeks
Six minute walk test( 6MWT) will be applied. The test evaluates six minute walking distance in meters accordance with ATS/ ERS statements.
2 secondary outcomes
Core stabilization assessment
Time frame: 8 weeks
Health-related quality of life
Time frame: 8 weeks
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 31 Jan 2023.
- Results publication: PubMed 32434700Tanriverdi 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.
- Results publication: PubMed 31273863Piraua 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.
- Results publication: PubMed 23108436Granacher 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.
- Results publication: PubMed 21869636Ogaya 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.
- Derived from this study: PubMed 38614379Durdu H, Demir R, Zeren M, Aydin E, Gunaydin ZY, Yigit Z. The Effect of Computerized Wobble Board and Core Stabilization Exercises on Balance Performance and Exercise Capacity in Patients With Heart Failure: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Aug;105(8):1429-1438. doi: 10.1016/j.apmr.2024.04.003. Epub 2024 Apr 12.
- Individual participant dataSharing planned: No. The datasets to be collected, will be available from the corresponding author on reasonable request.
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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.
Habibe DURDU, MSc principal investigator
Giresun University
Rengin DEMIR, Prof study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization group(CSG) and Wobble board group (WBG) in people with Heart Failure and Systolic Heart Failure, run by Giresun 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 4 inclusion and 9 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 31 Jan 2023. 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?
Functional balance assessment (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937790, which also lists 5 linked publications.
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 31 Jan 2023.