HydrotherapyNCT06131138
Aquatic Exercises VS Core Strengthening on Disability, Flexibility and Postural Stability in Weightlifters.
A study testing Aquatic exercises and Core strengthening in people with Hydrotherapy and Core Stability, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study is randomized and single blinded.Ethical approval is taken from ethical committee of Riphah international university, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A and group B through sealed envelope method by non probability convenient random sampling… Read more about this study
- Who is it for?
- Ages 20 to 35 years, men only
- Conditions the study is for
- Hydrotherapy, Core Stability, Resistance Training
- What is being tested?
- Aquatic exercises and Core strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2023to 20 Feb 2024
- 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 20 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age of participants between 20-35 years
- Experienced male weightlifters from past 6 months to in practice.
- Participants must have chronic low back pain for at least three months before enrollin
Who cannot join
- Patients with significant back pain who need rapid medical or surgical treatment.
- History of respiratory or heart diseases
- Water related anxiety or inability to adapt to aquatic environment.
- Participants with prior back surgery i.e. had surgery within six months.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Firehouse fitness gym
Sargodha, Punjab Province, 40100
Raheel Jutt, Masters, 03077818389
Laraib Iqbal, DPT
About this study
Official title: Effects of Aquatic Exercises and Core Strengthening on Disability, Flexibility and Postural Stability in Weightlifters With Chronic Low Back Pain.
The study is randomized and single blinded.Ethical approval is taken from ethical committee of Riphah international university, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A and group B through sealed envelope method by non probability convenient random sampling technique. Subjects in group A will receive aquatic exercises. Group B will receive core strengthening.
Read the detailed description
The objective of the study is to determine the effects of aquatic exercises verses core strengthening on disability, flexibility and postural stability in weightlifters with chronic low back pain. The study is randomized and single blinded. Ethical approval is taken from ethical committee of Riphah international university Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A and group B through sealed envelope method by non probability convenient random sampling technique. subjects in group A will receive Aquatic exercises. Group B will receive Core strengthening. The outcome measures will be assessed by modified Oswestry Low back disability index , Modified finger_tip to floor method and New York Posture Rating Chart. The data will be analyzed by SPSS, Version 25. Statistical significance is P=0.05.
- Conditions
- Hydrotherapy, Core Stability, Resistance Training, Low Back Pain
- Being tested
- Aquatic exercises, Core strengthening
- Keywords
- Aquatic exercises, Core strengthening, Weightlifters, chronic low back pain
- 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.
Aquatic exercisesOther
This include aquatic exercises thrice as week for 6 weeks.
Core strengtheningOther
This include core strengthening exercises thrice a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aquatic exercises | Experimental | Group A will perform aquatic exercises that includes abdominal hollowing, vertical downward press, lateral downard press, straight leg raising, trading water and deep water running. Three sessions per week for 6 weeks. Receives: Other: Aquatic exercises |
| Core strengthening | Experimental | Group B will perform core strengthening exercises that includes abdominal hollowing, side bridge, spine extension bridge, straight leg raise from prone, alternate arm and leg raise from quadruped and prone bridge. Three sessions per week for 6 weeks Receives: Other: Core strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Disability will be measured by modified Oswestry Low back disability index.
Measured: Pre and 6 week post international
Flexibility
Flexibility will be measured by modified Finger_tip to floor method.
Measured: Pre and 6 weeks post interventional
Postural stability
Postural stability will be measured by New York Posture Rating Chart
Measured: Pre and 6 weeks post interventional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start20 Oct 2023
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HydrotherapyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trials
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laraib Iqbal, DPT, Principal investigator, Study principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131138
- Sponsor's protocol ID
- REC/RCR&AHS/23/0440
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu F, Zhang M, Wang D, Hong Q, Zeng C, Chen W. Yoga compared to non-exercise or physical therapy exercise on pain, disability, and quality of life for patients with chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Sep 1;15(9):e0238544. doi: 10.1371/journal.pone.0238544. eCollection 2020.
PubMed 32870936Tagliaferri SD, Miller CT, Owen PJ, Mitchell UH, Brisby H, Fitzgibbon B, Masse-Alarie H, Van Oosterwijck J, Belavy DL. Domains of Chronic Low Back Pain and Assessing Treatment Effectiveness: A Clinical Perspective. Pain Pract. 2020 Feb;20(2):211-225. doi: 10.1111/papr.12846. Epub 2019 Nov 11.
PubMed 31610090Grabovac I, Dorner TE. Association between low back pain and various everyday performances : Activities of daily living, ability to work and sexual function. Wien Klin Wochenschr. 2019 Nov;131(21-22):541-549. doi: 10.1007/s00508-019-01542-7. Epub 2019 Sep 6.
PubMed 31493101Abadi FH, Sankaravel M, Zainuddin FF, Elumalai G, Razli AI. The effect of aquatic exercise program on low-back pain disability in obese women. J Exerc Rehabil. 2019 Dec 31;15(6):855-860. doi: 10.12965/jer.1938688.344. eCollection 2019 Dec.
PubMed 31938709Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
PubMed 34847915
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aquatic Exercises and Core Strengthening on Disability, Flexibility and Postural Stability in Weightlifters With Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT06131138
- Acronym / sponsor ID
- REC/RCR&AHS/23/0440
- Conditions
- Hydrotherapy, Core Stability, Resistance Training, Low Back Pain
- Keywords
- Aquatic exercises, Core strengthening, Weightlifters, chronic low back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 14 Nov 2023 (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.
The study is randomized and single blinded.Ethical approval is taken from ethical committee of Riphah international university, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A and group B through sealed envelope method by non probability convenient random sampling technique. Subjects in group A will receive aquatic exercises. Group B will receive core strengthening.
Detailed description
The objective of the study is to determine the effects of aquatic exercises verses core strengthening on disability, flexibility and postural stability in weightlifters with chronic low back pain. The study is randomized and single blinded. Ethical approval is taken from ethical committee of Riphah international university Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A and group B through sealed envelope method by non probability convenient random sampling technique. subjects in group A will receive Aquatic exercises. Group B will receive Core strengthening. The outcome measures will be assessed by modified Oswestry Low back disability index , Modified finger_tip to floor method and New York Posture Rating Chart. The data will be analyzed by SPSS, Version 25. Statistical significance is P=0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trials
| Arm | Type | Receives |
|---|---|---|
| Aquatic exercises | Experimental | Other: Aquatic exercisesGroup A will perform aquatic exercises that includes abdominal hollowing, vertical downward press, lateral downard press, straight leg raising, trading water and deep water running. Three sessions per week for 6 weeks. |
| Core strengthening | Experimental | Other: Core strengtheningGroup B will perform core strengthening exercises that includes abdominal hollowing, side bridge, spine extension bridge, straight leg raise from prone, alternate arm and leg raise from quadruped and prone bridge. Three sessions per week for 6 weeks |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of participants between 20-35 years
- Experienced male weightlifters from past 6 months to in practice.
- Participants must have chronic low back pain for at least three months before enrollin
Key exclusion criteria (4 listed)
- Patients with significant back pain who need rapid medical or surgical treatment.
- History of respiratory or heart diseases
- Water related anxiety or inability to adapt to aquatic environment.
- Participants with prior back surgery i.e. had surgery within six months.
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 |
|---|---|---|
| Aquatic exercisesThis include aquatic exercises thrice as week for 6 weeks. | Other | Aquatic exercises |
| Core strengtheningThis include core strengthening exercises thrice a week for 6 weeks | Other | Core strengthening |
Primary outcome
Disability
Time frame: Pre and 6 week post international
Disability will be measured by modified Oswestry Low back disability index.
Flexibility
Time frame: Pre and 6 weeks post interventional
Flexibility will be measured by modified Finger_tip to floor method.
Postural stability
Time frame: Pre and 6 weeks post interventional
Postural stability will be measured by New York Posture Rating Chart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 32870936Zhu F, Zhang M, Wang D, Hong Q, Zeng C, Chen W. Yoga compared to non-exercise or physical therapy exercise on pain, disability, and quality of life for patients with chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Sep 1;15(9):e0238544. doi: 10.1371/journal.pone.0238544. eCollection 2020.
- Background: PubMed 31610090Tagliaferri SD, Miller CT, Owen PJ, Mitchell UH, Brisby H, Fitzgibbon B, Masse-Alarie H, Van Oosterwijck J, Belavy DL. Domains of Chronic Low Back Pain and Assessing Treatment Effectiveness: A Clinical Perspective. Pain Pract. 2020 Feb;20(2):211-225. doi: 10.1111/papr.12846. Epub 2019 Nov 11.
- Background: PubMed 31493101Grabovac I, Dorner TE. Association between low back pain and various everyday performances : Activities of daily living, ability to work and sexual function. Wien Klin Wochenschr. 2019 Nov;131(21-22):541-549. doi: 10.1007/s00508-019-01542-7. Epub 2019 Sep 6.
- Background: PubMed 31938709Abadi FH, Sankaravel M, Zainuddin FF, Elumalai G, Razli AI. The effect of aquatic exercise program on low-back pain disability in obese women. J Exerc Rehabil. 2019 Dec 31;15(6):855-860. doi: 10.12965/jer.1938688.344. eCollection 2019 Dec.
- Background: PubMed 34847915Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
- Individual participant dataSharing planned: No
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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.
Laraib Iqbal, DPT principal investigator
Study principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic exercises and Core strengthening in people with Hydrotherapy and Core Stability, run by Riphah International University at 1 site in Pakistan.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Atif Javed, PP-DPT (+92-3317491071, atif.javed@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: Pre and 6 week post international). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06131138, which also lists 5 linked publications.
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 14 Nov 2023.