- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531017
The Effectiveness of Aquatherapy on Physical Performance and Fear of Falling in Geriatric Individuals With Low Back Pain
The Effectiveness of Aquatherapy on Physical Performance and Fear of Falling in Geriatric Individuals With Low Back Pain: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammed Samed Dalakçı Ph. D.
- Phone Number: +905445325572
- Email: samed.dalakci@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 years and older
- Having chronic low back pain for more than 3 months
- Medical clearance to participate in exercise, including aquatic exercise
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aqua therapy
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.
|
Participants in the aquatherapy group will receive a structured, supervised aquatic exercise program conducted in a therapeutic 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 and will consist of warm-up, main exercise, and cool-down phases. The intervention type is classified as a non-pharmacological, exercise-based procedural intervention. The program will be delivered in a temperature-controlled therapeutic pool and will utilize the physical properties of water, including buoyancy, viscosity, and hydrostatic pressure. No pharmacological agents will be administered during the intervention. If required for safety and exercise facilitation, standard aquatic equipment such as flotation devices may be used. Balance outcomes will be assessed using the Biodex Balance System, a computerized postural stability assessment device, which provides objective measureme |
|
Active Comparator: Conservative Treatment Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 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.
|
From enrollment to the end of treatment at 6 weeks
|
|
Physical performance
Time Frame: 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.
|
From enrollment to the end of treatment at 6 weeks
|
|
Falls Efficacy Scale-International
Time Frame: 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.
|
From enrollment to the end of treatment at 6 weeks
|
|
Dinamic and static balance
Time Frame: 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.
|
Measurements will be conducted at baseline (initial assessment) and 6 weeks of intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- m.s.dalakcı
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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