- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06922981
Periodized Resistance and Aerobic Training in Non-Specific Chronic Low Back Pain
Comparison Between Periodized Resistance and Aerobic Training Programs on Nonspecific Chronic Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 12613
- Faculty of Physical Therapy, Cairo Universi
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Giza, Egypt, 12613
- Faculty of Physical Therapy, Cairo Universi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Male or female participants with nonspecific (nonspecific pathology) chronic (> 12 weeks) low back pain (localized below the costal margin and above the gluteal fold) (Owen et al., 2020).
- Participants aged between 18 to 45 years (Wewege et al., 2018).
- Participants with Body Mass Index (BMI) 18.5-29.9 Kg/m2.
- VAS score 3-8 cm (Pieler-Bruha, 2009).
- ODI score 10-60 (Pieler-Bruha, 2009).
Exclusion Criteria:
Participants will be excluded if they did not meet the inclusion criteria mentioned above such as pain due to or associated with:
- Pregnancy
- Infection
- Fracture
- Tumor
- Structural deformity (e.g. scoliosis)
- Radicular syndrome or cauda equine syndrome
- Inflammatory disorders (Owen et al., 2020)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: resistance group
Nineteen male and female patients aged 18 to 45 years, diagnosed with NSCLBP were recruited through referrals from orthopedic surgeons.The exercise program included upper and lower body resistance training exercises including leg press, lateral pull down, abdominal crunch, Swiss ball abdominal crunch, and prone superman exercises, utilizing free weights, machines, and bodyweight exercises.
The therapist performed a one-repetition maximum (1 RM) test at baseline to determine the initial exercise loads.
Participants then performed exercises at 50% to 70% of their 1 RM value.
This process of periodic 1 RM testing and training at 50% to 70% of the value is repeated every two weeks till the end of the study.
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Thirty-eight male and female patients aged 18-45 years, diagnosed with NSCLBP will be recruited through direct referrals from orthopedic surgeons, based on their availability to participate, thus a sample of convenience will be used, Participants will be randomly assigned as follows: Group A: Patients in group (A) (n=19) will receive a periodized resistance exercise program. Group B: The patients in group (B) (n=19) will receive a periodized aerobic exercise program
Other Names:
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Experimental: aerobic group
Nineteen male and female patients aged 18 to 45 years, diagnosed with NSCLBP were recruited through referrals from orthopedic surgeons.The periodized aerobic training (AT) program consisted of three sessions per week.
Each Exercise session consisted of a 5-minute warm-up, 30 minutes of aerobic exercise, and a 5-minute cool-down.
Backward walking was performed on a motorized treadmill.The participants began with 10-15 minutes of exercise at 40-55% HRR (RPE=11-12, light) during the first two weeks, 20-30 minutes of exercise at 55-70% HRR (RPE=12-13, somewhat hard) during the third and fourth week, then 30 minutes of exercise at 70-85% HRR (RPE=14-16, hard) for the remainder of the study.
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Thirty-eight male and female patients aged 18-45 years, diagnosed with NSCLBP will be recruited through direct referrals from orthopedic surgeons, based on their availability to participate, thus a sample of convenience will be used, Participants will be randomly assigned as follows: Group A: Patients in group (A) (n=19) will receive a periodized resistance exercise program. Group B: The patients in group (B) (n=19) will receive a periodized aerobic exercise program
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity Measured by Visual Analogue Scale (VAS)
Time Frame: baseline (week 0) and at the end of intervention (week 8)
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Pain intensity will be assessed using the Visual Analogue Scale (VAS), a 10 cm horizontal scale where 0 cm represents "no pain" and 10 cm represents "worst imaginable pain."
Participants will rate their pain at rest and during movement.
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baseline (week 0) and at the end of intervention (week 8)
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Disability Level Measured by the Oswestry Disability Index (ODI)
Time Frame: baseline (week 0) and at the end of intervention (week 8)
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Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a validated 10-item questionnaire measuring limitations in daily activities due to pain.
Each item is scored from 0 to 5, with total scores ranging from 0% (no disability) to 100% (severe disability).
Higher scores indicate greater disability.
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baseline (week 0) and at the end of intervention (week 8)
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Fear of movement measured by Tampa Scale of Kinesiophobia (TSK)
Time Frame: baseline (week 0) and at the end of intervention (week 8)
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Fear of movement related to pain will be assessed using the Tampa Scale of Kinesiophobia (TSK), a validated 17-item questionnaire designed to measure fear of movement and injury-related avoidance behavior.
Each item is scored on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), with total scores ranging from 17 (low fear) to 68 (high fear).
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baseline (week 0) and at the end of intervention (week 8)
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Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test
Time Frame: baseline (week 0) and at the end of intervention (week 8)
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Abdominal endurance will be assessed using the Abdominal Muscular Endurance Test, which requires participants to perform a curl-up to the rhythm of a metronome for as long as possible.
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baseline (week 0) and at the end of intervention (week 8)
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Back Isometric Muscular Endurance Measured by the Biering-Sørensen Back Endurance Test Back Isometric Muscular Endurance Back Isometric Muscular Endurance Measured by the Biering-Sørensen Back Endurance Test (BSBE)
Time Frame: baseline (week 0) and at the end of intervention (week 8)
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Back endurance will be assessed using the Biering-Sørensen Back Endurance Test (BSBE), which evaluates the endurance of the lumbar extensor muscles.
The test involves the participant holding a prone position on a plinth with the upper body suspended and supported only by the pelvis and legs, maintaining this position for as long as possible.
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baseline (week 0) and at the end of intervention (week 8)
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Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer
Time Frame: baseline (week 0) and at the end of intervention (week 8)
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Latissimus dorsi muscle strength will be assessed using a hand-held dynamometer.
Participants will be instructed to perform a manual muscle contraction while the dynamometer is placed on the posterior surface of distal humerus.
resistance was applied in the direction of shoulder flexion.
The maximal force generated during the contraction will be recorded in newtons (N).
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baseline (week 0) and at the end of intervention (week 8)
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Gluteus Maximus Muscle Strength Measured by Hand-Held Dynamometer
Time Frame: baseline (week 0) and at the end of intervention (week 8)
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Gluteus maximus muscle strength will be assessed using a hand-held dynamometer.
Participants will be asked to perform a hip extension against the dynamometer placed 5 c m proximal to the knee joint.
The maximal force exerted during the movement will be recorded in newtons (N) to assess muscle strength.
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baseline (week 0) and at the end of intervention (week 8)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cashin AG, Booth J, McAuley JH, Jones MD, Hubscher M, Traeger AC, Fried K, Moseley GL. Making exercise count: Considerations for the role of exercise in back pain treatment. Musculoskeletal Care. 2022 Jun;20(2):259-270. doi: 10.1002/msc.1597. Epub 2021 Oct 21.
- Calatayud J, Guzman-Gonzalez B, Andersen LL, Cruz-Montecinos C, Morell MT, Roldan R, Ezzatvar Y, Casana J. Effectiveness of a Group-Based Progressive Strength Training in Primary Care to Improve the Recurrence of Low Back Pain Exacerbations and Function: A Randomised Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8326. doi: 10.3390/ijerph17228326.
- Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
- Wewege MA, Booth J, Parmenter BJ. Aerobic vs. resistance exercise for chronic non-specific low back pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2018;31(5):889-899. doi: 10.3233/BMR-170920.
- Lorenz D, Morrison S. CURRENT CONCEPTS IN PERIODIZATION OF STRENGTH AND CONDITIONING FOR THE SPORTS PHYSICAL THERAPIST. Int J Sports Phys Ther. 2015 Nov;10(6):734-47.
- Tjosvoll SO, Mork PJ, Iversen VM, Rise MB, Fimland MS. Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study. BMC Sports Sci Med Rehabil. 2020 May 8;12:30. doi: 10.1186/s13102-020-00181-0. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- periodized RT and AT in NSCLBP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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