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The effect of closed and open kinetic chain exercises combined with blood flow restriction therapy on pain, muscle strength, and function in patients with knee osteoarthritis

Protocol summary

Study aim
To compare the effects of closed versus open kinetic chain exercises combined with blood flow restriction on pain, quadriceps strength, and function in patients with knee osteoarthritis.
Design
A single-blind parallel-group RCT of 40 participants (20 per group), randomized 1:1 by a computer-generated sequence to CKC+BFR or OKC+BFR. The outcome assessor will be blinded.
Settings and conduct
The study will be conducted in Baghdad, Iraq. Eligible patients will be randomly allocated to either intervention group. Treatment will be provided by a physiotherapist, while outcomes will be assessed by a blinded assessor.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 45–60 years, knee osteoarthritis grade II–III, BMI 25–35 kg/m², VAS pain 30–80 mm, malalignment ≤10°, and ability to walk. Exclusion criteria: Knee replacement, recent intra-articular injection, cardiovascular or vascular disease, neurological disorders, or BFR contraindications.
Intervention groups
Participants will be allocated to two groups. Group A will receive closed kinetic chain exercises with blood flow restriction (BFR), while Group B will receive open kinetic chain exercises with BFR. Both groups will receive 12 treatment sessions.
Main outcome variables
Pain will be assessed using VAS, quadriceps strength using a handheld dynamometer, and physical function using WOMAC. Outcomes will be measured before and after the intervention..

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260613069777N1
Registration date: 2026-08-17, 1405/05/26
Registration timing: prospective

Last update: 2026-08-17, 1405/05/26
Update count: 0
Registration date
2026-08-17, 1405/05/26
Registrant information
Name
Taqwa Salwan
Name of organization / entity
Country
Iraq
Phone
+964 781 294 2798
Email address
taqwa98.ts@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-11, 1405/06/20
Expected recruitment end date
2027-02-09, 1405/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of closed and open kinetic chain exercises combined with blood flow restriction therapy on pain, muscle strength, and function in patients with knee osteoarthritis
Public title
The effect of exercises with blood flow restriction on pain, muscle strength and function in people with osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged 45–60 years. Clinical and radiographic diagnosis of knee osteoarthritis, Kellgren–Lawrence grade II–III. Body mass index (BMI) between 25–35 kg/m². Knee pain intensity between 30–80 mm on a 100-mm Visual Analog Scale (VAS) during daily activities. Mild to moderate lower limb malalignment, defined as varus or valgus deformity ≤10°. Ability to walk independently with or without minimal assistive devices. Willingness to participate and provide written informed consent.
Exclusion criteria:
History of total knee replacement surgery. Intra-articular corticosteroid or hyaluronic acid injection within the past 3 months. Uncontrolled hypertension, unstable angina, or recent myocardial infarction. Peripheral vascular disease, history of deep vein thrombosis (DVT), or clotting disorders. Neurological disorders affecting lower limb strength or mobility. Contraindications to blood flow restriction training, such as severe varicosities, vascular insufficiency, or severe edema.
Age
From 45 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly allocated to two intervention groups in a 1:1 ratio using a computer-generated random sequence. Randomization will be performed using Random Allocation Software. Gender matching will be considered to ensure balanced distribution of male and female participants between the two groups. Allocation concealment will be maintained using sequentially numbered, sealed, opaque envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor will be blinded to group allocation throughout the study. The assessor will perform the baseline and post-intervention outcome measurements without knowing whether each participant has been allocated to the closed kinetic chain exercise with blood flow restriction group or the open kinetic chain exercise with blood flow restriction group. The physiotherapist providing the intervention and the participants will not be blinded due to the nature of the exercise interventions.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Mirkhani Street (East Nosrat), Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2026-08-01, 1405/05/10
Ethics committee reference number
IR.TUMS.FNM.REC.1405.075

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified

Primary outcomes

1

Description
Pain intensity
Timepoint
Before the intervention and after completion of the 12-session intervention.
Method of measurement
Pain intensity will be measured using a 100-mm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain).

Secondary outcomes

1

Description
Quadriceps muscle strength
Timepoint
Before the intervention and after completion of the 12 treatment sessions.
Method of measurement
Quadriceps muscle strength will be measured using a handheld dynamometer

2

Description
Physical function and symptoms related to knee osteoarthritis
Timepoint
Before the intervention and after completion of the 12 treatment sessions.
Method of measurement
Measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire.

Intervention groups

1

Description
Intervention group 1: Closed kinetic chain exercises combined with blood flow restriction (CKC+BFR). Participants will receive a supervised 4-week rehabilitation program consisting of 3 sessions per week (12 sessions in total). The closed kinetic chain exercise program will include squat-to-chair, step-up, and Swiss-ball leg press exercises. Blood flow restriction will be applied during exercise at 40–80% of the individually determined limb occlusion pressure (LOP). Exercises will be performed using a low load of 20–30% of one-repetition maximum (1RM), following a 30–15–15–15 repetition scheme with 30–40 seconds of rest between sets. Exercise load will be progressively increased according to participant tolerance while remaining within the prescribed low-load range. Each session will include a standardized warm-up consisting of 5 minutes of low-intensity stationary cycling or brisk walking followed by 2–3 minutes of gentle knee range-of-motion exercises. At the end of the session, participants will perform quadriceps and hamstring stretching, with each stretch held for 30 seconds and repeated twice. All sessions will be supervised by a licensed physiotherapist to ensure correct technique, safety, and adherence to the intervention protocol.
Category
Rehabilitation

2

Description
Intervention group 2: Open kinetic chain exercises combined with blood flow restriction (OKC+BFR). Participants will receive a supervised 4-week rehabilitation program consisting of 3 sessions per week (12 sessions in total). The open kinetic chain exercise program will include seated knee extension, straight leg raise, and hamstring curl exercises. Blood flow restriction will be applied during exercise at 40–80% of the individually determined limb occlusion pressure (LOP). Exercises will be performed using a low load of 20–30% of one-repetition maximum (1RM), following a 30–15–15–15 repetition scheme with 30–40 seconds of rest between sets. Exercise resistance will be progressively increased using external resistance such as ankle weights or elastic resistance bands according to participant tolerance while remaining within the prescribed low-load range. Each session will include a standardized warm-up consisting of 5 minutes of low-intensity stationary cycling or brisk walking followed by 2–3 minutes of gentle knee range-of-motion exercises. At the end of the session, participants will perform quadriceps and hamstring stretching, with each stretch held for 30 seconds and repeated twice. All sessions will be supervised by a licensed physiotherapist to ensure correct technique, safety, and adherence to the intervention protocol.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
AL-Karama Teaching Hospital
Full name of responsible person
Taqwa Salwan Alkhateeb
Street address
Alkharkh
City
Baghdad
Postal code
10011
Phone
+964 781 294 2798
Fax
Email
taqwa98.ts@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
AlBari Medical Center
Full name of responsible person
Dr. Ahmed Abdulbari
Street address
Harithia
City
Baghdad
Postal code
10092
Phone
+964 770 029 3993
Fax
Email
taqwa98.ts@gmail.com
Web page address

3

Recruitment center
Name of recruitment center
Kinetic Center
Full name of responsible person
Mohammed Abdulhissain
Street address
karrada
City
Baghdad
Postal code
10069
Phone
+964 786 017 8977
Email
Mohammed.pt@oulook.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Vice Chancellor for Research and Technology, Sixth Foor, Central University Organization, Corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Taqwa Salwan Alkhateeb
Position
Ms.c candidate
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Alkharkh
City
Baghdad
Province
Baghdad
Postal code
10069
Phone
+964 781 294 2798
Fax
Email
taqwa98.ts@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behrouz Attarbashi Moghadam
Position
Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
attarbashi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behrouz Attarbashi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 7753 3939
Fax
Email
attarbashi@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially sharable after unidentified individuals.
When the data will become available and for how long
Access period starts 3 months after the article is published.
To whom data/document is available
For researchers working in academic, scientific and hospital institutions.
Under which criteria data/document could be used
Researchers working in the field of knee osteoarthritis and exercise therapy.
From where data/document is obtainable
Applicants for documentation can contact Dr. Attarbashi Moghadam via email: attarbashi@sina.tums.ac.ir
What processes are involved for a request to access data/document
Once they have the necessary criteria, the information will be provided to them within a month.
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