| CTRI Number |
CTRI/2025/03/081575 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Home-based exercise program (HEP) and concentric versus eccentric-based stair training program (CSTP versus ESTP) for pain and function in knee osteoarthritis |
|
Scientific Title of Study
|
A two-phase double-blinded randomised controlled trial on structured home-based exercise program (HEP) and concentric versus eccentric-based stair training program (CSTP versus ESTP) for pain and function in knee osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abid Hasan Khan |
| Designation |
MPT Fellow |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01787378201 |
| Fax |
|
| Email |
abidhasankhan1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
(JUST), Jashore-7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Kazi Md Azman Hossain |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University
of Science and Technology (JUST), Jashore-7408, Bangladesh. |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jashore University of Science and Technology JUST |
Jashore-7408, Bangladesh |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Md Kabir Hossain |
Dr. M R Khan Medical Centre, Jashore University of Science and Technology, Jahsore-7408, Bangladesh. |
Room no: 306, 2nd
Floor, Department of
Physiotherapy and
Rehabilitation, Jashore
University of Science
and Technology
(JUST), Jashore-7408,
Bangladesh.
|
01778315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Department of Physiotherapy and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Concentric-Based Ascending Stair Training Program (CSTP) – Phase II |
Participants will ascend a stairwell from the first to the sixth floor (22 stairs per floor) for 8-week. The exercise is progressive, with Stage 1 starting at 2 repetitions of 110 stairs per rep, increasing to Stage 2 (4 reps), Stage 3 (8 reps), and Stage 4 (16 reps). Sessions are conducted three times per week including warm-up (5 min) and cool-down (5 min), with heart rate and blood pressure monitoring before and after each session. |
| Comparator Agent |
Control Group – Phase I |
Participants in the control group will not receive an exercise regimen but will take non-steroidal anti-inflammatory drugs (NSAIDs) as per their condition and follow general lifestyle education for 8-week. Weekly telephone follow-ups with automated messages will be conducted to ensure adherence to prescribed medication and lifestyle modifications |
| Comparator Agent |
Control Group – Phase II |
Participants in this control group will maintain their usual lifestyle without engaging in structured stair-walking exercises for 8-week. They will not take NSAIDs but will receive general health and lifestyle education. Follow-ups will be conducted to track their adherence to a healthy lifestyle. |
| Intervention |
Eccentric-Based Descending Stair Training Program (ESTP) – Phase II |
Participants will descend from the sixth to the first floor using a controlled, eccentric-focused approach for 8-week. Similar to the ascending stair walking group, Stage 1 starts with 2 repetitions of 110 stairs per rep, progressing through Stages 2 (4 reps), 3 (8 reps), and 4 (16 reps). The same session frequency and monitoring procedures are applied. Sessions are conducted three times per week including warm-up (5 min) and cool-down (5 min), with heart rate and blood pressure monitoring before and after each session. |
| Intervention |
Home-Based Exercise Program (HEP) – Phase I |
Participants in the HEP group will perform structured exercises targeting knee strength and mobility for 8-week. The
program includes light walking and joint mobility exercises (5 minutes), followed by strengthening exercises using TheraBands (knee flexion-extension, terminal knee extension, leg press, calf raises, and mini-squats). The progression is as follows: Stage 1 (3 sets of 10 reps with a yellow band), Stage 2 (3 sets of 15 reps with a red band), and Stage 3 (3 sets of 20 reps with a green band). Sessions are conducted three times per week, with a cooldown of light stretching - Hamstrings, Quadriceps, Hip flexor, Outer hip (3 reps, 15-second hold). |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
For Phase I - Individuals will be included in this trial if (1) ages 45 – 70 for both men and women; (2) the presence of knee OA for at least six months following American College of Rheumatology criteria; (3) able to walk without the use of any aids and able to flex the knee beyond 90 degrees; (4) anterior-posterior bilateral standing radiograph presents Kellgren and Lawrence Grade II/III knee OA; (5) having smartphone for watching video tutorial.
For Phase II - Individuals will be included if (1) complete Phase I home-based exercise program (HBEP); (2) pain subsides during walking and staring
|
|
| ExclusionCriteria |
| Details |
For Phase I - Individuals will be excluded if (1) knee surgery has been performed in the previous twelve months; (2) lumbar radiculopathy, vascular claudication, severe anterior-sided knee pain resulting from patella-femoral syndrome or chondromalacia, as well as further neurological, muscular, or joint conditions that could impair the function of the lower limbs; (3) visible malformation of the knee, either varus or valgus; (4) Received hyaluronic acid or corticosteroid injections within three months of study enrollment; (5) pregnancy (6) BMI over 30.
For Phase II - Individuals will be excluded if – (1) present signs of knee OA following American College of Rheumatology criteria;16 (2) the presence of unusual cardiac response during the six-minute walk test and staring.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain (NPRS), pressure pain threshold (Algometer), and functional ability (WOMAC) |
At baseline, week-8, week-16 and week-24 follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| muscle strength (sphygmomanometer), range of motion(goniometer), aerobic capacity (6MWT), and quality of life(SF-36 |
At baseline, week-8, week-16 and week-24 follow-up |
|
|
Target Sample Size
|
Total Sample Size="247"
Sample Size from India="0"
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)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2025 |
| 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 Yet Recruiting |
| 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 two-phase, double-blinded
randomized controlled trial will evaluate the effectiveness of a structured home-based
exercise program (HEP) and concentric versus eccentric-based stair training
program (CSTP versus ESTP) for individuals with knee osteoarthritis (OA). This
will be conducted for 16 weeks with a 24-week follow-up, the study aims to
assess pain, functional improvement, and long-term benefits. Primary outcomes
include pain severity, pressure pain threshold, and functional ability, while
secondary measures focus on muscle strength, range of motion, aerobic capacity,
and quality of life. Findings will provide evidence for accessible and
sustainable rehabilitation strategies for knee OA, contributing to improved
patient outcomes and non-pharmacological self-management options. |