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Comparison of High-Intensity Interval Training With Moderate-Intensity Continuous Training in Chronic Non-Specific Low Back Pain Patients
10 juni 2026 bijgewerkt door: Dr. Ariba Sohail (PT), Dow University of Health Sciences
Comparison of High-Intensity Interval Training With Moderate-Intensity Connuous Training In Chronic Non-Specific Low Back Pain Patients: Randomized Clinical Trial
The goal of this clinical trial is to compare the HIIT with MICT in chronic non-specific low back pain patients. The main questions it aims to answer are:
- The broad aim of the study is to compare HIIT with MICT in pain reduction in chronic non-specific low back pain patients.
- The purpose of this research is to compare HIIT with MICT on disability and quality of life among chronic non-specific low back pain patients.
- It also attempts to investigate the relationship between the baseline attributes and outcome variables.
Researcher will compare the HIIT to MICT to see the effects on CNSLBP
Participants will be:
- Allocated to HIIT or MICT group for 6 weeks.
- Assessed pre and post intervention.
- Continuously monitored during treatment sessions.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ariba Dr. Ariba Sohail (PT)
- Telefoonnummer: +923480218683
- E-mail: aribasohail123@gmail.com
Studie Locaties
-
-
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Karachi, Pakistan
- Werving
- Dr. Ariba Sohail (PT)
-
Contact:
- Ariba Sohail
- Telefoonnummer: +923480218683
- E-mail: aribasohail123@gmail.com
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Referred patients of back pain persisting for > 12 weeks with no identifiable specific cause or underlying pathology from DUH OPD who meet the eligibility criteria.
- Age group 20-48 with either gender.
- NPRS score ranging between 3 and 5 (mild to moderate).
- Modified ODI score is mild to moderate.
Exclusion Criteria:
- Any client with a specific cause of LBP (neurological problems, fractures, malignancy, infections, or rheumatic diseases such as RA or ankylosing spondylitis).
- Any client with cardiopulmonary problems (recent myocardial infarction, uncontrolled hypertension, asthma, COPD).
- Any client with musculoskeletal disorders [injuries limiting exercises, spine injuries, recent trauma (fracture), scoliosis by Forward Adam's test].
- Any client with metabolic conditions (thyroid problems, uncontrolled diabetes).
- Pregnancy / first 3-6 months postpartum.
- Recent surgery.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: High-Intensity Interval Training
A total of 40 participants will be enrolled in this group.
Sessions will be conducted 3 times a week, each session lasting for 25 minutes.
The duration breakdown is as follows: 3 minutes of warm-up, 6 bouts of HIIT (1 min of HIIT at 85-90% of HRmax, 2 min of recovery at 74-80% of HRmax), and 4 min of cool down.
The intensity will be monitored using HR and the Borg Rating of Perceived Exertion.
The mode of exercise will involve brisk walk and jog.
At the end of each session, participants will perform 5-10 minutes stretching exercises targeting major muscle groups.
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High-Intensity Interval Training
|
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Actieve vergelijker: Moderate-Intensity Continuous Training
A total of 40 participants will be enrolled in this group.
Sessions will be conducted 5 times a week, each session lasting for 46 minutes.
The duration breakdown is as follows: 3 minutes of warm-up, 40 min of HIIT (at 60-70% of HRmax), and 3 min of cool down.
The intensity will be monitored using HR and Borg Rating of Perceived Exertion.
The mode of exercise will involve normal walk.
At the end of each session, participants will perform 5-10 minutes stretching exercises targeting major muscle groups.
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Moderate-Intensity Continuous Training
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Numeric Pain Rating Score (NPRS)
Tijdsspanne: 6 weeks
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Low back pain persisting for > 12 weeks with no identifiable specific cause or underlying pathology Score: Mild to moderate (3-5)
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6 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Modified Oswestry Disability Index for disability
Tijdsspanne: 6 weeks
|
Disability percentage derived from 10-item ODI scores 20-40% considered mild to moderate and eligible.
|
6 weeks
|
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Short Form-12 for Quality of Life
Tijdsspanne: 6 weeks
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6 weeks
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Modified Bruce Treadmill protocol for CV endurance
Tijdsspanne: 6 weeks
|
6 weeks
|
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Bioelectrical Impedance Analysis (BIA) for body composition
Tijdsspanne: 6 weeks
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6 weeks
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height and weight for Body Mass Index
Tijdsspanne: 6 weeks
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6 weeks
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Waist Hip Ratio for fat distribution
Tijdsspanne: 6 weeks
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6 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Ariba Sohail, Dow University of Health Sciences
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.
- Jensen MP, McFarland CA. Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain. 1993 Nov;55(2):195-203. doi: 10.1016/0304-3959(93)90148-I.
- Vasold KL, Parks AC, Phelan DML, Pontifex MB, Pivarnik JM. Reliability and Validity of Commercially Available Low-Cost Bioelectrical Impedance Analysis. Int J Sport Nutr Exerc Metab. 2019 Jul 1;29(4):406-410. doi: 10.1123/ijsnem.2018-0283.
- Kotte EM, DE Groot JF, Bongers BC, Winkler AM, Takken T. Validity and Reproducibility of a New Treadmill Protocol: The Fitkids Treadmill Test. Med Sci Sports Exerc. 2015 Oct;47(10):2241-7. doi: 10.1249/MSS.0000000000000657.
- Kontodimopoulos N, Pappa E, Niakas D, Tountas Y. Validity of SF-12 summary scores in a Greek general population. Health Qual Life Outcomes. 2007 Sep 28;5:55. doi: 10.1186/1477-7525-5-55.
- Cheak-Zamora NC, Wyrwich KW, McBride TD. Reliability and validity of the SF-12v2 in the medical expenditure panel survey. Qual Life Res. 2009 Aug;18(6):727-35. doi: 10.1007/s11136-009-9483-1. Epub 2009 May 8.
- da Silva T, Mills K, Brown BT, Pocovi N, de Campos T, Maher C, Hancock MJ. Recurrence of low back pain is common: a prospective inception cohort study. J Physiother. 2019 Jul;65(3):159-165. doi: 10.1016/j.jphys.2019.04.010. Epub 2019 Jun 14.
- Sheahan PJ, Nelson-Wong EJ, Fischer SL. A review of culturally adapted versions of the Oswestry Disability Index: the adaptation process, construct validity, test-retest reliability and internal consistency. Disabil Rehabil. 2015;37(25):2367-74. doi: 10.3109/09638288.2015.1019647. Epub 2015 Mar 4.
- Verbrugghe J, Agten A, Stevens S, Hansen D, Demoulin C, O Eijnde B, Vandenabeele F, Timmermans A. Exercise Intensity Matters in Chronic Nonspecific Low Back Pain Rehabilitation. Med Sci Sports Exerc. 2019 Dec;51(12):2434-2442. doi: 10.1249/MSS.0000000000002078.
- Cerini T, Hilfiker R, Riegler TF, Felsch QTM. 12 weeks high intensity interval training versus moderate intensity continuous training in chronic low back pain subjects: a randomised single-blinded feasibility study. Arch Physiother. 2022 May 2;12(1):12. doi: 10.1186/s40945-022-00136-3.
- Atakan MM, Guzel Y, Bulut S, Kosar SN, McConell GK, Turnagol HH. Six high-intensity interval training sessions over 5 days increases maximal oxygen uptake, endurance capacity, and sub-maximal exercise fat oxidation as much as 6 high-intensity interval training sessions over 2 weeks. J Sport Health Sci. 2021 Jul;10(4):478-487. doi: 10.1016/j.jshs.2020.06.008. Epub 2020 Jun 18.
- Shokri P, Zahmatyar M, Falah Tafti M, Fathy M, Rezaei Tolzali M, Ghaffari Jolfayi A, Nejadghaderi SA, Sullman MJM, Kolahi AA, Safiri S. Non-spinal low back pain: Global epidemiology, trends, and risk factors. Health Sci Rep. 2023 Sep 4;6(9):e1533. doi: 10.1002/hsr2.1533. eCollection 2023 Sep.
- Fernandez-Rodriguez R, Alvarez-Bueno C, Cavero-Redondo I, Torres-Costoso A, Pozuelo-Carrascosa DP, Reina-Gutierrez S, Pascual-Morena C, Martinez-Vizcaino V. Best Exercise Options for Reducing Pain and Disability in Adults With Chronic Low Back Pain: Pilates, Strength, Core-Based, and Mind-Body. A Network Meta-analysis. J Orthop Sports Phys Ther. 2022 Aug;52(8):505-521. doi: 10.2519/jospt.2022.10671. Epub 2022 Jun 19.
- Custers P, Van de Kelft E, Eeckhaut B, Sabbe W, Hofman A, Debuysscher A, Van Acker G, Maes G. Clinical Examination, Diagnosis, and Conservative Treatment of Chronic Low Back Pain: A Narrative Review. Life (Basel). 2024 Aug 29;14(9):1090. doi: 10.3390/life14091090.
- 35. Mikat, RP. Validity And Reliability of Waist-To-Hip Ratio Measurements From Dual Digital-Photograph Anthropometry. Medicine & Science in Sports & Exercise. May 2001. 33(5):p S241.
- Shirai Y, Momosaki R, Kokura Y, Kato Y, Okugawa Y, Shimizu A. Validation of Asian Body Mass Index Cutoff Values for the Classification of Malnutrition Severity According to the Global Leadership Initiative on Malnutrition Criteria in Patients with Chronic Obstructive Pulmonary Disease Exacerbations. Nutrients. 2022 Nov 10;14(22):4746. doi: 10.3390/nu14224746.
- 26. Weir CB, Jan A. BMI Classification Percentile and Cut off Points [Internet]. PubMed. Treasure Island (FL): StatPearls Publishing; 2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK541070/
- 25. Kauser S, Ahmed B, Aslam S. Effects of Moderate Intensity Continuous Training on Body Composition and Aerobic Fitness in Female College Students. Vol. 6, The Sky-International Journal of Physical Education and Sports Sciences.
- 23. Amir R, Jehangir F, Muhammad M, Ahsan NJ, Adnan T. Frequency and Determinants of Chronic Lower Back Pain Among Patients Presenting To Primary Care Clinics in Pakistan: A Cross-Sectional Analysis. Journal of Rawalpindi Medical College. 2023 Dec 30;27(4).
- 21. Sarfraz M, Shadmehr A, Naz E, Ali M, Rahim A. Comparison of Short-Term Effects of High-Intensity Interval Training vs Moderate Intensity Continuous Training on Anthropometric Characteristics of Overweight Young Women. Pakistan Journal of Medical and Health Sciences. 2022 Aug 31;16(8):729-32.
- Berge J, Hjelmesaeth J, Hertel JK, Gjevestad E, Smastuen MC, Johnson LK, Martins C, Andersen E, Helgerud J, Storen O. Effect of Aerobic Exercise Intensity on Energy Expenditure and Weight Loss in Severe Obesity-A Randomized Controlled Trial. Obesity (Silver Spring). 2021 Feb;29(2):359-369. doi: 10.1002/oby.23078.
- D'Amuri A, Sanz JM, Capatti E, Di Vece F, Vaccari F, Lazzer S, Zuliani G, Dalla Nora E, Passaro A. Effectiveness of high-intensity interval training for weight loss in adults with obesity: a randomised controlled non-inferiority trial. BMJ Open Sport Exerc Med. 2021 Jul 20;7(3):e001021. doi: 10.1136/bmjsem-2020-001021. eCollection 2021.
- 18. Uysal HŞ, Korkmaz S, Aksakallı O. The effect of six-week bodyweight high-intensity interval training on the performance of young female athletes. Mehmet Akif Ersoy Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi. 2024 May 2;12(1):15-25.
- 17. Dregney TM, Thul CM, Linde JA, Lewis BA. Affective responses to high-intensity interval training relative to moderate-intensity continuous training. Physical Activity and Health. 2023;7(1):229-38.
- Poon ET, Chan KW, Wongpipit W, Sun F, Wong SH. Acute Physiological and Perceptual Responses to Whole-Body High-Intensity Interval Training Compared with Equipment-Based Interval and Continuous Training. J Sports Sci Med. 2023 Sep 1;22(3):532-540. doi: 10.52082/jssm.2023.532. eCollection 2023 Sep.
- 15. Tanaka K, Matsuo T. Global trends in high-intensity interval training (HIIT). The Journal of Physical Fitness and Sports Medicine. 2021 May 25;10(3):127-8.
- Gajanand T, Cox ER, Keating SE, Brown WJ, Hordern MD, Burton NW, Chachay VS, Gomersall SR, Fassett RG, Coombes JS. Low-volume combined aerobic and resistance high-intensity interval training in type 2 diabetes: a randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Oct 7;10(4):e002046. doi: 10.1136/bmjsem-2024-002046. eCollection 2024.
- 13. Kabir MS, Yadav S, Biswas S, Pradhan S, Geantă VA. Aerobic VS Anaerobic Exercise on Body Composition and Hormonal Adaptations in Athletes and Non-Athletes: A Randomized Controlled Trial. Journal of Coaching and Sports Science [Internet]. 2025 Jan 27;4(1):52-65. Available from: https://journal.foundae.com/index.php/jcss/article/view/553
- Verbrugghe J, Hansen D, Demoulin C, Verbunt J, Roussel NA, Timmermans A. High Intensity Training Is an Effective Modality to Improve Long-Term Disability and Exercise Capacity in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Oct 14;18(20):10779. doi: 10.3390/ijerph182010779.
- van Eetvelde JS, Timmermans AAA, Coninx K, Kempeneers K, Meeus M, Marneffe W, Meus T, Meuwissen I, Roussel NA, Stassijns G, Verbrugghe J. Technology supported High Intensity Training in chronic non-specific low back pain (the Techno-HIT trial): study protocol of a randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Oct 7;10(4):e002180. doi: 10.1136/bmjsem-2024-002180. eCollection 2024.
- Verbrugghe J, Agten A, Stevens S, Hansen D, Demoulin C, Eijnde BO, Vandenabeele F, Timmermans A. High Intensity Training to Treat Chronic Nonspecific Low Back Pain: Effectiveness of Various Exercise Modes. J Clin Med. 2020 Jul 27;9(8):2401. doi: 10.3390/jcm9082401.
- Pinho H, Neves M, Costa F, Silva AG. Pain intensity and pain sensitivity are not increased by a single session of high-intensity interval aerobic exercise in individuals with chronic low back pain: A randomized and controlled trial. Musculoskelet Sci Pract. 2023 Aug;66:102824. doi: 10.1016/j.msksp.2023.102824. Epub 2023 Jul 4.
- 4. Aziz R, Niaz M, Ashraf A, Pari S, Ali R. Prevalence of Work Related Low Back Pain Among Clinical Physical Therapists. Vol. 15. 2021.
- Momen Majumder MS, Hakim F, Bandhan IH, Razzaque MA, Zahid-Al-Quadir A, Ahmed S, Choudhury MR, Haq SA, Zaman MM. Low back pain in the Bangladeshi adult population: a cross-sectional national survey. BMJ Open. 2022 Sep 8;12(9):e059192. doi: 10.1136/bmjopen-2021-059192.
- Feleke M, Getachew T, Shewangizaw M, Gebremickael A, Boshe M. Prevalence of low back pain and associated factors among medical students in Wachemo University Southern Ethiopia. Sci Rep. 2024 Oct 9;14(1):23518. doi: 10.1038/s41598-024-72597-4.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
14 mei 2026
Primaire voltooiing (Geschat)
1 december 2026
Studie voltooiing (Geschat)
1 december 2026
Studieregistratiedata
Eerst ingediend
5 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 juni 2026
Eerst geplaatst (Werkelijk)
12 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
10 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB-4535
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .