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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06131138
Other study ID # REC/RCR&AHS/23/0440
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date February 20, 2024

Study information

Verified date November 2023
Source Riphah International University
Contact Muhammad Atif Javed, PP-DPT
Phone +92-3317491071
Email atif.javed@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 technique. Subjects in group A will receive aquatic exercises. Group B will receive core strengthening.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 33
Est. completion date February 20, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Aquatic exercises
This include aquatic exercises thrice as week for 6 weeks.
Core strengthening
This include core strengthening exercises thrice a week for 6 weeks

Locations

Country Name City State
Pakistan Firehouse fitness gym Sargodha Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Abadi 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. — View Citation

Grabovac 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. — View Citation

Hlaing 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. — View Citation

Tagliaferri 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disability Disability will be measured by modified Oswestry Low back disability index. Pre and 6 week post international
Primary Flexibility Flexibility will be measured by modified Finger_tip to floor method. Pre and 6 weeks post interventional
Primary Postural stability Postural stability will be measured by New York Posture Rating Chart Pre and 6 weeks post interventional
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