Periodized Resistance and Aerobic Training in Non-Specific Chronic Low Back Pain

NCT06922981 | Completed

• 1 other identifier: periodized RT and AT in NSCLBP
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to compare the effectiveness of two forms of periodized exercise training programs (resistance and aerobic ) using the best recommended parameters (volume, intensity, rest period, and frequency) on the best available outcome measures (pain, disability, fear of movement, back and abdominal muscular endurance, upper body strength (latissimus dorsi muscle),and lower body strength ( gluteus maximus )

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (7)

• Pain Intensity Measured by Visual Analogue Scale (VAS)

  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.

  baseline (week 0) and at the end of intervention (week 8)

• Disability Level Measured by the Oswestry Disability Index (ODI)

  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.

  baseline (week 0) and at the end of intervention (week 8)

• Fear of movement measured by Tampa Scale of Kinesiophobia (TSK)

  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).

  baseline (week 0) and at the end of intervention (week 8)

• 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

  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.

  baseline (week 0) and at the end of intervention (week 8)

• 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)

  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.

  baseline (week 0) and at the end of intervention (week 8)

• Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer

  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).

  baseline (week 0) and at the end of intervention (week 8)

• Gluteus Maximus Muscle Strength Measured by Hand-Held Dynamometer

  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.

  baseline (week 0) and at the end of intervention (week 8)

Study Arms (2)

resistance group

EXPERIMENTAL

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.

Behavioral: resistance training program

aerobic group

EXPERIMENTAL

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.

Behavioral: resistance training program

Interventions

resistance training program BEHAVIORAL

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

Also known as: aerobic training program

aerobic group; resistance group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Pregnancy
• Infection
• Fracture
• Tumor
• Structural deformity (e.g. scoliosis)
• Radicular syndrome or cauda equine syndrome
• Inflammatory disorders (Owen et al., 2020)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Physical Therapy, Cairo Universi

Cairo, 12613, Egypt

Location

Faculty of Physical Therapy, Cairo Universi

Giza, 12613, Egypt

Location

Related Publications (6)

• 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.

  PMID: 34676659 RESULT

• 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.

  PMID: 33187076 RESULT

• 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.

  PMID: 33922389 RESULT

• 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.

  PMID: 29889056 RESULT

• 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.

  PMID: 26618056 RESULT

• 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.

  PMID: 32411374 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: April 11, 2025
• Study Start: December 25, 2023
• Primary Completion: May 25, 2024
• Study Completion: June 25, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

EG (2)