BalanceNCT07344662
The Effect of Hemsball in the Older People
A study testing Experimental: Hemsball in people with Balance and Kinesiophobia, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of hemsball activity on balance, kinesiophobic attitudes, and frailty levels in older male individuals. The research was conducted as a parallel-group pre-test-post-test randomized controlled trial. Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Balance, Kinesiophobia, Frailty
- What is being tested?
- Experimental: Hemsball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Nov 2025
- 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 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- Failing to attend the event three times in a row Having serious chronic illnesses that restrict participation in the event (such as cardiovascular, musculoskeletal, respiratory system diseases..) Having a lower extremity fracture within the last year Having undergone any surgery within the last month Having been diagnosed with any neuropsychiatric disorder (dementia, Alzheimer's disease, traumatic brain injury, Parkinson's disease, stroke, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hemsball Efficacy on Balance, Kinesiophobic Attitude and Frailty in the Elderly: A Randomized Controlled Trial
This study aimed to determine the effect of hemsball activity on balance, kinesiophobic attitudes, and frailty levels in older male individuals. The research was conducted as a parallel-group pre-test-post-test randomized controlled trial. The reporting of the study utilized the CONSORT 2017 extension evaluating non-pharmacological interventions. The study was conducted with 86 older male individuals using a parallel-group pre-test-post-test randomized controlled trial design. The hemsball activity was structured by the research team and lasted for eight weeks, three days a week, for 60 minutes each day. Data were collected using pre-tests planned before randomization, immediately after obtaining written consent from the individuals, and post-tests in the eighth week of the study. Data were collected using a Personal Information Form, the Berg Balance Scale, the Tampa Kinesiophobia Scale, and the Edmonton Frailty Scale. Data were analyzed using a generalized linear model. This research found that hemsball activity is an effective intervention in improving balance and reducing kinesiophobia and frailty in older male individuals. Through this research, a new type of intervention that improves balance and reduces kinesiophobia and frailty levels in older individuals has been added to the literature.
- Conditions
- Balance, Kinesiophobia, Frailty, Older People, Male, Activities
- Being tested
- Experimental: Hemsball
- Medical subject headings
- Kinesiophobia, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: HemsballOther
The intervention program was developed within the theoretical framework of the book "Hemsball for All Ages," and expert opinions were sought from both the author of the book and the president of the Hemsball Federation. The program was conducted in groups, and game times were determined for each group. The program continued with groups of five individuals per hour, totaling 10 people, and lasted approximately five hours over half a day with 44 individuals. The older people participants in the Hemsball activity followed the principle of continuity for eight weeks, three days a week, with 60 minutes of Hemsball activity each day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Hemsball group Receives: Other: Experimental: Hemsball |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
This form consists of 13 questions designed by researchers to determine individuals' personal characteristics based on the literature.
Measured: It was completed at the beginning of the study and at the end of 8 weeks.
Berg Balance Scale
This scale was developed to determine individuals' levels of balance. The scale consists of 14 items, each scored between 0 (poor) and 4 (best). The total score on the scale ranges from 0 to 56. A higher score indicates better balance.
Measured: at the start of the study and at the end of 8 weeks
Tampa Kinesiophobia Scale
This scale assesses individuals' work-related actions, injury/re-injury, and fear-avoidance behaviors. The scale consists of 17 items, scored from 1 (strongly disagree) to 4 (strongly agree). Four items are reverse-scored (items 4, 8, 12, and 16). The total score ranges from 17 to 68. An increased score indicates increased kinesiophobia.
Measured: at the start of the study and at the end of 8 weeks
Edmonton Frailty Scale
This scale assesses the vulnerability of older individuals across dimensions including "cognitive status, general health status, functional independence, social support, medication use, nutrition, mood, urinary incontinence, and functional performance." The scale consists of nine dimensions and 11 items. The total score obtainable from the scale ranges from 0 to 17.
Measured: at the start of the study and at the end of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jun 2025
- Primary completion1 Sep 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Şükran İRİBALCI, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344662
- Sponsor's protocol ID
- SelcukU-SBF-Şİ-02
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hemsball Efficacy on Balance, Kinesiophobic Attitude and Frailty in the Elderly: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07344662
- Acronym / sponsor ID
- SelcukU-SBF-Şİ-02
- Conditions
- Balance, Kinesiophobia, Frailty, Older People, Male, Activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 15 Jan 2026 (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.
This study aimed to determine the effect of hemsball activity on balance, kinesiophobic attitudes, and frailty levels in older male individuals. The research was conducted as a parallel-group pre-test-post-test randomized controlled trial. The reporting of the study utilized the CONSORT 2017 extension evaluating non-pharmacological interventions. The study was conducted with 86 older male individuals using a parallel-group pre-test-post-test randomized controlled trial design. The hemsball activity was structured by the research team and lasted for eight weeks, three days a week, for 60 minutes each day. Data were collected using pre-tests planned before randomization, immediately after obtaining written consent from the individuals, and post-tests in the eighth week of the study. Data were collected using a Personal Information Form, the Berg Balance Scale, the Tampa Kinesiophobia Scale, and the Edmonton Frailty Scale. Data were analyzed using a generalized linear model. This research found that hemsball activity is an effective intervention in improving balance and reducing kinesiophobia and frailty in older male individuals. Through this research, a new type of intervention that improves balance and reduces kinesiophobia and frailty levels in older individuals has been added to the literature.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Experimental: HemsballHemsball group |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Failing to attend the event three times in a row Having serious chronic illnesses that restrict participation in the event (such as cardiovascular, musculoskeletal, respiratory system diseases..) Having a lower extremity fracture within the last year Having undergone any surgery within the last month Having been diagnosed with any neuropsychiatric disorder (dementia, Alzheimer's disease, traumatic brain injury, Parkinson's disease, stroke, etc.)
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 |
|---|---|---|
| Experimental: HemsballThe intervention program was developed within the theoretical framework of the book "Hemsball for All Ages," and expert opinions were sought from both the author of the book and the president of the Hemsball Federation. The program was conducted in groups, and game times were determined for each group. The program continued with groups of five individuals per hour, totaling 10 people, and lasted approximately five hours over half a day with 44 individuals. The older people participants in the Hemsball activity followed the principle of continuity for eight weeks, three days a week, with 60 minutes of Hemsball activity each day. | Other | Intervention |
Primary outcome
Personal Information Form
Time frame: It was completed at the beginning of the study and at the end of 8 weeks.
This form consists of 13 questions designed by researchers to determine individuals' personal characteristics based on the literature.
Berg Balance Scale
Time frame: at the start of the study and at the end of 8 weeks
This scale was developed to determine individuals' levels of balance. The scale consists of 14 items, each scored between 0 (poor) and 4 (best). The total score on the scale ranges from 0 to 56. A higher score indicates better balance.
Tampa Kinesiophobia Scale
Time frame: at the start of the study and at the end of 8 weeks
This scale assesses individuals' work-related actions, injury/re-injury, and fear-avoidance behaviors. The scale consists of 17 items, scored from 1 (strongly disagree) to 4 (strongly agree). Four items are reverse-scored (items 4, 8, 12, and 16). The total score ranges from 17 to 68. An increased score indicates increased kinesiophobia.
Edmonton Frailty Scale
Time frame: at the start of the study and at the end of 8 weeks
This scale assesses the vulnerability of older individuals across dimensions including "cognitive status, general health status, functional independence, social support, medication use, nutrition, mood, urinary incontinence, and functional performance." The scale consists of nine dimensions and 11 items. The total score obtainable from the scale ranges from 0 to 17.
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 15 Jan 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Experimental: Hemsball in people with Balance and Kinesiophobia, run by Selcuk 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 0 inclusion and 1 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 15 Jan 2026. 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?
Personal Information Form (time frame: It was completed at the beginning of the study and at the end of 8 weeks.). The study lists 4 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 15 Jan 2026.