- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07645859
Comparison of High-Intensity Interval Training With Moderate-Intensity Continuous Training in Chronic Non-Specific Low Back Pain Patients
10 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
80
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Ariba Dr. Ariba Sohail (PT)
- Numer telefonu: +923480218683
- E-mail: aribasohail123@gmail.com
Lokalizacje studiów
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Karachi, Pakistan
- Rekrutacyjny
- Dr. Ariba Sohail (PT)
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Kontakt:
- Ariba Sohail
- Numer telefonu: +923480218683
- E-mail: aribasohail123@gmail.com
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Numeric Pain Rating Score (NPRS)
Ramy czasowe: 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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Modified Oswestry Disability Index for disability
Ramy czasowe: 6 weeks
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Disability percentage derived from 10-item ODI scores 20-40% considered mild to moderate and eligible.
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6 weeks
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Short Form-12 for Quality of Life
Ramy czasowe: 6 weeks
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6 weeks
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Modified Bruce Treadmill protocol for CV endurance
Ramy czasowe: 6 weeks
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6 weeks
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Bioelectrical Impedance Analysis (BIA) for body composition
Ramy czasowe: 6 weeks
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6 weeks
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height and weight for Body Mass Index
Ramy czasowe: 6 weeks
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6 weeks
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Waist Hip Ratio for fat distribution
Ramy czasowe: 6 weeks
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6 weeks
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Ariba Sohail, Dow University of Health Sciences
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
14 maja 2026
Zakończenie podstawowe (Szacowany)
1 grudnia 2026
Ukończenie studiów (Szacowany)
1 grudnia 2026
Daty rejestracji na studia
Pierwszy przesłany
5 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
12 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
12 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
10 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB-4535
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Brisk walk and jog
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Istanbul University - Cerrahpasa (IUC)ZakończonyStwardnienie rozsiane | Zaburzenia chodu, neurologiczne | Problem z kończyną górnąIndyk