Low Back PainNCT07531017
The Effectiveness of Aquatherapy on Physical Performance and Fear of Falling in Geriatric Individuals With Low Back Pain
A study testing Aquatherapy and Conservative Treatment in people with Low Back Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Aquatherapy and Conservative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2026to 18 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years and older
- Having chronic low back pain for more than 3 months
- Medical clearance to participate in exercise, including aquatic exercise
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Aquatherapy, Conservative Treatment
- Keywords
- Aquatherapy, low back pain, Fear of Falling, Physical performance
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquatherapyOther
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 TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start28 Apr 2026
- Primary completion18 Oct 2026
- Study completion18 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Samed DALAKÇI, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531017
- Sponsor's protocol ID
- m.s.dalakcı
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Aquatherapy on Physical Performance and Fear of Falling in Geriatric Individuals With Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07531017
- Acronym / sponsor ID
- m.s.dalakcı
- Conditions
- Low Back Pain
- Keywords
- Aquatherapy, low back pain, Fear of Falling, Physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 18 Oct 2026 (actual)
- Study completion
- 18 Oct 2026 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aqua therapy | Experimental | Other: AquatherapyParticipants 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. |
| Conservative Treatment Group | Active comparator | Other: Conservative TreatmentParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 years and older
- Having chronic low back pain for more than 3 months
- Medical clearance to participate in exercise, including aquatic exercise
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AquatherapyParticipants 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 | Other | Aqua therapy |
| Conservative TreatmentParticipants 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 Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatherapy and Conservative Treatment in people with Low Back Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.