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NCT Number: NCT07531017

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammed Samed Dalakçı Ph. D.

CONTACT

[email protected]

+905445325572

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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