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

NCT07531017 | Not Yet Recruiting

• 1 other identifier: m.s.dalakcı
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized controlled trial designed to investigate 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 lasting longer than three months will be randomly assigned to either an Aquatherapy Group or a Conservative Treatment Group. The aquatherapy intervention will be conducted in a pool environment, utilizing the physical properties of water (buoyancy, viscosity, and hydrostatic pressure) to improve balance, trunk stability, and lower extremity strength. The conservative treatment group will receive standard land-based physiotherapy, including trunk stabilization, stretching, lower extremity strengthening, and balance exercises. Both groups will participate in supervised sessions three times per week for six weeks, with each session lasting approximately 45-60 minutes. Outcome measures will include balance assessed using a Biodex posturography system, physical performance evaluated by the 1-Minute Sit-to-Stand Test, and fear of falling measured using the Falls Efficacy Scale-International (FES-I). The findings of this study are expected to provide evidence on the effectiveness of aquatherapy as a comprehensive rehabilitation approach in reducing fall risk and improving functional outcomes in older adults with chronic low back pain.

Conditions

Low Back Pain

Keywords

Aquatherapy; low back pain; Fear of Falling; Physical performance

Outcome Measures

Primary Outcomes (4)

• Balance

  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

• Dinamic and static balance

  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 after 6 weeks of intervention.

• Physical performance

  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

  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

Study Arms (2)

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.

Other: Aquatherapy

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.

Other: Conservative Treatment

Interventions

Aquatherapy OTHER

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.

Aqua therapy

Conservative Treatment OTHER

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.

Conservative Treatment Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of lower extremity or spinal surgery within the last 6 months. Contraindications or allergy to pool water (e.g., open wounds, infections, etc.).
• Severe cognitive impairment (inability to follow instructions).

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Muhammed Samed Dalakçı Ph. D.

CONTACT

+905445325572; samed.dalakci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share