| CTRI Number |
CTRI/2026/02/104795 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [PhD Thesis] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of A Guided Home Physiotherapy Exercise Programme In People With Long-Term Inflammatory Back Arthritis |
|
Scientific Title of Study
|
Effect Of A Structured Unsupervised Physiotherapy Programme In Axial Spondyloarthropathy: A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Vaidya |
| Designation |
PhD Scholar |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy N 6 Cidco Chhatrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8378979567 |
| Fax |
|
| Email |
vaidyaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tabish Fahim |
| Designation |
Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy N 6 Cidco Chhatrapati Sambhajinagar (Aurangabad)
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9718481337 |
| Fax |
|
| Email |
drtabishfahim4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Vaidya |
| Designation |
PhD Scholar |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy N 6 Cidco Chhatrapati Sambhajinagar (Aurangabad)
MAHARASHTRA
431003
India |
| Phone |
8378979567 |
| Fax |
|
| Email |
vaidyaphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aditya Vaidya |
| Address |
MGM School of Physiotherapy
N6 Cidco, Chh. Sambhajinagar (Aurangabad), India 431003 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aditya Vaidya |
Dr Hedgewar Rugnalaya |
Gut No 4 Near Gajanan Maharaj Mandir Garkheda Parisar Chhatrapati Sambhajinagar (Aurangabad) 431009
Aurangabad
MAHARASHTRA |
8378979567
vaidyaphysio@gmail.com |
| Aditya Vaidya |
MGM School of Physiotherapy |
N 6 Cidco Chhtrapati Sambhajinagar (Aurangabad)431003
Aurangabad
MAHARASHTRA |
8378979567
vaidyaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee for Research On Human Subjects MGM Institute of Health Sciences, Navi Mumbai 410209 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M450||Ankylosing spondylitis of multiplesites in spine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Structured Physiotherapy Exercise Programme with Adherance Support |
Intervention Includes Structured Physiotherapy Exercises Programme provided as guided exercise video with adherence support given with Weekly Phone Calls and daily log book.
Follow up visits on 1st 3rd 6th 9th and 12th month over the period of 1 year |
| Comparator Agent |
Structured Physiotherapy Exercise Programme without Adherance Support |
Control group Includes Structured Physiotherapy Exercises Programme provided as printed exercise pamphlet without any kind of adherence support.
Follow up visits on 1st 3rd 6th 9th and 12th month over the period of 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed of axial Spondyloarthropathy by rheumatologist
Disease duration more than 3 months
Stable Medical treatment for at least 3 months prior to enrollment (NSAISs Biologics DMARDs)
Willingness and ability to comply with study procedures including follow-up visits
Able to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Presence of severe comorbidities (uncontrolled cardiovascular disease severe respiratory conditions) contraindicating exercise
Recent spinal or joint surgery within last 6 months
Severe spinal deformity or neurological deficits limiting exercise participation
Pregnancy or breastfeeding
Active infection or inflammatory conditions other than axSpA
Cognitive impairment or psychiatric illness interfering with understanding of the protocol or adherence
Inability to comply with study procedures.
Participation in other conflicting clinical trials or physiotherapy programs within last 3 months
Presence of any implanted devices or intrauterine contraceptive devices (IUDs) that are MRI-unsafe
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spondylo-Arthritis Research Consortium Canada (SPARCC) Score (Spine & SIJ) |
Baseline and 12th Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a.Bath Ankylosing Spondylitis Functional Index (BASFI)
b.Bath Ankylosing Spondylitis Metrological Index (BASMI)
c.Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
d.Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
e.Exercise Adherence Rating Scale (EARS) |
Baseline, 3rd Month, 6th Month, 9th Month and 12th Month |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
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)
|
09/03/2026 |
| 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="2"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 controlled study aims to evaluate the effectiveness of a structured unsupervised (home-based) physiotherapy programme in patients with axial spondyloarthritis (inflammatory arthritis of the spine). Eligible participants will be randomly allocated into intervention and control groups. The intervention group will receive a structured, standardized home exercise programme focusing on spinal mobility, flexibility, strengthening, and postural correction with adherance support, while the control group will receive standard care/advice with no adherance support. Outcomes will be assessed at baseline, 3rd month, 6th month, 9 month and post-intervention using validated measures of pain, functional status, spinal mobility, and disease activity. The study intends to determine whether a structured unsupervised physiotherapy programme with adherance support can improve clinical outcomes and functional capacity in individuals with axial spondyloarthritis. |