NCT07344662

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

December 30, 2025

Last Update Submit

January 13, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Personal Information Form

    This form consists of 13 questions designed by researchers to determine individuals' personal characteristics based on the literature.

    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.

    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.

    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.

    at the start of the study and at the end of 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Hemsball group

Other: Experimental: Hemsball

Control group

NO INTERVENTION

No intervention

Interventions

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.

Intervention

Eligibility Criteria

Age65 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selçuk Üniversitesi

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KinesiophobiaFrailtyMotor Activity

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 15, 2026

Study Start

June 1, 2025

Primary Completion

September 1, 2025

Study Completion

November 1, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations