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临床试验/NCT07344662
NCT07344662已完成不适用

The Effect of Hemsball Efficacy on Balance, Kinesiophobic Attitude and Frailty in the Elderly: A Randomized Controlled Trial

Selcuk University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Personal Information Form

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Being 65 years of age or older being male Having no problems with verbal communication Having no disability including blindness, hearing loss, or limb impairment Having sound mental and psychological health

排除标准

  • 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.)

结局指标

主要结局

Personal Information Form

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Şükran İRİBALCI

Assoc.Prof

Selcuk University

研究点 (1)

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