| CTRI Number |
CTRI/2026/02/103229 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Calisthenic versus Aerobic Exercises on Pain, Muscle Endurance, Lumbar Lordosis and Quality of Life in individuals with Chronic Non-Specific Low Back Pain |
|
Scientific Title of Study
|
Effect of Calisthenic versus Aerobic Exercises on Pain, Muscle Endurance, Lumbar Lordosis and Quality of Life in Chronic Non-Specific Low Back Pain: A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Analiz Olinda Da Costa Campos |
| Designation |
Postgraduate student (Orthopaedic Physiotherapy) |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room No. 18, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8788421399 |
| Fax |
|
| Email |
analizdacostacampos@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kage |
| Designation |
Professor and Dean, Department of Orthopaedic Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room No. 18, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kage |
| Designation |
Professor and Dean, Department of Orthopaedic Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room No. 18, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Analiz Da Costa Campos |
| Address |
KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka-590010 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vijay Kage |
KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka-590010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Kage |
KLES Dr. Prabhakar Kore Hospital and MRC Nehru Nagar, Belagavi, 590010 |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room No. 18, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
9845271899
vijaykage@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committe, KLEU Institute of Physiotherapy, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic exercises combined with conventional physiotherapy |
Participants allocated to the comparator group will receive the same conventional physiotherapy protocol consisting of Hot Moist Pack application for 15 minutes in prone lying and Interferential Therapy with a carrier frequency of 4000 Hz, beat frequency of 80–100 Hz, at a strong but comfortable sensory intensity for 20 minutes. In addition, they will undergo a supervised aerobic exercise program using a stationary bicycle ergometer. The cycling protocol will begin with a total duration of 20 minutes in week 1 and will be progressively increased each week up to 35 minutes by week 4, while maintaining a moderate intensity of approximately 60 revolutions per minute. Sessions will be conducted three times per week for four weeks under the supervision of a qualified physiotherapist. |
| Intervention |
Calisthenic exercises combined with conventional physiotherapy |
Participants allocated to the intervention group will receive conventional physiotherapy consisting of Hot Moist Pack application for 15 minutes in prone lying and Interferential Therapy with a carrier frequency of 4000 Hz, beat frequency of 80–100 Hz, at a strong but comfortable sensory intensity for 20 minutes. In addition, they will perform a supervised, progressive calisthenic exercise program targeting trunk strength, endurance, neuromuscular control, and spinal stability. The program will include bodyweight exercises such as quadruped, curl-ups, push-ups, bridges, squats, lunges, side bridges, hip hinges, and overhead squats, with session duration progressing from 25 minutes during weeks 1–2 to 30 minutes during weeks 3–4. Training will be conducted three times per week for four weeks under the supervision of a qualified physiotherapist. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals of all genders aged 18–35 years.
2. Individuals diagnosed with chronic non-specific low back pain lasting for at least 3 months.
3. Pain intensity between 3 and 7 on the Numeric Pain Rating Scale (NPRS) at baseline.
4. Able to perform basic physical activity and follow exercise instructions.
5. Willing to participate and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Specific spinal pathology (fracture, infection, tumor, inflammatory spondyloarthropathy).
2. Clinical spinal instability or significant segmental hypermobility on examination.
3. Neurological compromise or radiculopathy consistent with nerve-root compression.
4. Prior spinal surgery or recent major spinal trauma.
5. Severe cardiorespiratory disease or other medical contraindications to aerobic or exercise therapy.
6. Pregnancy or within six months postpartum. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain using Numeric Pain Rating Scale (NPRS)
2. Trunk flexors endurance using Biering-Sorensen Test
3. Trunk extensors endurance using McGill Trunk Flexor Endurance Test |
1. Pain will be assessed pre-intervention and post intervention over four weeks.
2. Trunk flexors endurance will be assessed pre-intervention and post intervention over four weeks.
3. Trunk extensors endurance will be assessed pre-intervention and post intervention over four weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Lumbar Lordosis using Pelvic Inclinometer
2. Quality of life using Modified Oswestry Disability Questionnaire (MODQ) |
1. Lumbar lordosis will be assessed pre-intervention and post intervention over four weeks.
2. Quality of life will be assessed pre-intervention and post intervention over four weeks. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized clinical trial aims to compare the effects of calisthenic exercises and aerobic exercises on pain, trunk muscle endurance, lumbar lordosis, and quality of life in individuals aged 18–35 years with chronic non-specific low back pain. Low back pain is a major cause of disability among young adults, often associated with reduced physical activity, poor posture, and muscle deconditioning. Exercise therapy is recommended as a first-line conservative treatment; however, the relative effectiveness of different exercise modalities remains unclear. In this study, participants will be randomly allocated into two groups. Both groups will receive conventional physiotherapy including Hot Moist Pack and Interferential Therapy. Group A will additionally perform a progressive calisthenic exercise program focusing on core stability and bodyweight strengthening, while Group B will undergo a progressive stationary bicycle aerobic exercise program. Treatment will be provided three times per week for four weeks under supervision. Outcomes will be assessed at baseline and at the end of the intervention using the Numeric Pain Rating Scale, trunk endurance tests, pelvic inclinometer for lumbar lordosis, and the Modified Oswestry Disability Questionnaire. The findings of this trial are expected to help determine the more effective exercise-based rehabilitation approach for managing chronic non-specific low back pain in young adults. |