- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07645859
Comparison of High-Intensity Interval Training With Moderate-Intensity Continuous Training in Chronic Non-Specific Low Back Pain Patients
2026년 6월 10일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ariba Dr. Ariba Sohail (PT)
- 전화번호: +923480218683
- 이메일: aribasohail123@gmail.com
연구 장소
-
-
-
Karachi, 파키스탄
- 모병
- Dr. Ariba Sohail (PT)
-
연락하다:
- Ariba Sohail
- 전화번호: +923480218683
- 이메일: aribasohail123@gmail.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
High-Intensity Interval Training
|
|
활성 비교기: 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.
|
Moderate-Intensity Continuous Training
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Numeric Pain Rating Score (NPRS)
기간: 6 weeks
|
Low back pain persisting for > 12 weeks with no identifiable specific cause or underlying pathology Score: Mild to moderate (3-5)
|
6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Modified Oswestry Disability Index for disability
기간: 6 weeks
|
Disability percentage derived from 10-item ODI scores 20-40% considered mild to moderate and eligible.
|
6 weeks
|
|
Short Form-12 for Quality of Life
기간: 6 weeks
|
6 weeks
|
|
|
Modified Bruce Treadmill protocol for CV endurance
기간: 6 weeks
|
6 weeks
|
|
|
Bioelectrical Impedance Analysis (BIA) for body composition
기간: 6 weeks
|
6 weeks
|
|
|
height and weight for Body Mass Index
기간: 6 weeks
|
6 weeks
|
|
|
Waist Hip Ratio for fat distribution
기간: 6 weeks
|
6 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ariba Sohail, Dow University of Health Sciences
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 14일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2026년 6월 5일
QC 기준을 충족하는 최초 제출
2026년 6월 10일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 10일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-4535
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Brisk walk and jog에 대한 임상 시험
-
Istanbul University - Cerrahpasa (IUC)완전한