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临床试验/NCT07531017
NCT07531017尚未招募不适用

The Effectiveness of Aquatherapy on Physical Performance and Fear of Falling in Geriatric Individuals With Low Back Pain: A Randomized Controlled Trial

Kirsehir Ahi Evran Universitesi0 个研究点目标入组 45 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
主要终点
Balance

研究概览

简要总结

This randomized controlled trial is designed to evaluate the effects of aquatherapy on physical performance, balance, and fear of falling in older adults with chronic low back pain. Participants aged 65 years and older, with low back pain persisting for more than three months, will be randomly allocated to either an Aquatherapy Group or a Conservative Treatment Group.

The aquatherapy intervention will be delivered in a supervised therapeutic pool environment and will consist of a structured exercise program performed three times per week for six weeks (18 sessions in total). Each session will last approximately 45-60 minutes and will include standardized warm-up, main exercise, and cool-down phases. The intervention will utilize the physical properties of water, including buoyancy, viscosity, and hydrostatic pressure, to facilitate postural control, enhance trunk stability, and improve lower extremity muscle strength. The intervention is classified as a non-pharmacological, exercise-based rehabilitation program. No pharmacological agents will be used during the intervention.

The conservative treatment group will receive standard land-based physiotherapy, which will include trunk stabilization exercises, stretching exercises, lower extremity strengthening, and balance training, delivered under supervision with the same frequency and duration as the aquatherapy group.

Outcome measures will be assessed at baseline and post-intervention. Balance performance will be evaluated using the Biodex Balance System, a computerized posturography device providing objective measures of postural stability. Physical performance will be assessed using the 1-Minute Sit-to-Stand Test (1MSTS), and fear of falling will be measured using the Falls Efficacy Scale-International (FES-I).

This study is expected to provide evidence regarding the effectiveness of aquatherapy as a comprehensive rehabilitation approach for improving functional outcomes and reducing fall-related concerns in older adults with chronic low back pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Aged 65 years and older
  • Having chronic low back pain for more than 3 months
  • Medical clearance to participate in exercise, including aquatic exercise

排除标准

  • History of lower extremity or spinal surgery within the last 6 months
  • Contraindications to aquatic exercise or pool environment (e.g., open wounds, active skin infections)
  • Severe cognitive impairment resulting in inability to follow instructions

研究组 & 干预措施

Aqua therapy

Experimental

Participants in the aquatherapy group will receive a structured, supervised exercise program conducted in a pool environment. The intervention will last for 6 weeks, with sessions performed three times per week, totaling 18 sessions. Each session will last approximately 45-60 minutes, including warm-up, main exercise, and cool-down phases. The program will utilize the physical properties of water, such as buoyancy, viscosity, and hydrostatic pressure, to improve balance (static and dynamic), trunk stability, and lower extremity strength.

干预措施: Aquatherapy (Other)

Conservative Treatment Group

Active Comparator

Participants in the conservative treatment group will receive a structured, supervised land-based physiotherapy program for 6 weeks, three times per week, totaling 18 sessions. Each session will last approximately 45-60 minutes and will include exercises, stretching, lower extremity strengthening, and balance training aimed at improving physical function and postural control.

干预措施: Conservative Treatment (Other)

结局指标

主要结局

Balance

时间窗: From enrollment to the end of treatment at 6 weeks

Balance will be assessed using the Biodex Balance System, an objective posturography device that evaluates static and dynamic balance by measuring an individual's ability to maintain stability on a movable platform. The system provides quantitative data on postural sway and stability indices, reflecting overall balance performance.

Dinamic and static balance

时间窗: Measurements will be conducted at baseline (initial assessment) and after 6 weeks of intervention.

Balance will be assessed using the Biodex Balance System, an objective posturography device that evaluates static and dynamic balance by measuring an individual's ability to maintain stability on a movable platform. The system provides quantitative data on postural sway and stability indices, reflecting overall balance performance.

Physical performance

时间窗: From enrollment to the end of treatment at 6 weeks

Physical performance will be assessed using the 1-Minute Sit-to-Stand Test, which measures lower extremity strength and functional capacity. Participants are instructed to repeatedly stand up from and sit down on a chair as many times as possible within one minute. The total number of completed repetitions is recorded as an indicator of physical performance and lower limb functional ability.

Falls Efficacy Scale-International

时间窗: From enrollment to the end of treatment at 6 weeks

Fear of falling will be assessed using the Falls Efficacy Scale-International, a validated questionnaire that evaluates an individual's concern about falling during various daily activities. Participants rate their level of concern on a Likert scale, with higher scores indicating greater fear of falling and lower confidence in performing activities without falling.

Dinamic and static balance

时间窗: Measurements will be conducted at baseline (initial assessment) and 6 weeks of intervention.

Balance will be assessed using the Biodex Balance System, an objective posturography device that evaluates static and dynamic balance by measuring an individual's ability to maintain stability on a movable platform. The system provides quantitative data on postural sway and stability indices, reflecting overall balance performance.

次要结局

未报告次要终点

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Samed DALAKÇI

Ph.D.

Kirsehir Ahi Evran Universitesi

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