The Effectiveness of Aquatherapy on Physical Performance and Fear of Falling in Geriatric Individuals With Low Back Pain

NCT07531017 | Not Yet Recruiting

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

Brief Summary

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.

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 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 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

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 to aquatic exercise or pool environment (e.g., open wounds, active skin infections)
• Severe cognitive impairment resulting in 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: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share