Effects of Blood Flow Restriction Training With Low Intensity Exercises in Knee Osteoarthritis

July 15, 2024 updated by: Riphah International University

Effects of Blood Flow Restriction Training With Low Intensity Exercises on Pain,Range of Motion and Quality of Life in Knee Osteoarthritis

The aim of the study is to examine the effects of blood flow restriction training(BFRT) with low intensity exercises on pain, range of motion and quality of life in Knee Osteoarthritis. A randomized clinical trial will be conducted at Lahore general hospital. Non-probability convenience sampling will be used, and 36 subjects, age 40-65 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the study is to examine the effects of blood flow restriction training(BFRT) with low intensity exercises on pain, range of motion and quality of life in Knee Osteoarthritis. A randomized clinical trial will be conducted at Lahore general hospital. Non-probability convenience sampling will be used, and 36 subjects, age 40-65 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria. Both groups will receive Ultrasound therapy for 7 minutes, as common treatment. Group A will be treated with Blood flow restriction training with low intensity exercises and Group B will be treated with baseline treatment only. 3 sessions per week and total 12 sessions for 4 weeks. The outcome measures will be conducted through NPRS, Womac index for osteoarthritis,kellgren and lawrence scale and goniometry before and after 4 weeks. Data will be analyzed using SPSS software version 26.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Lahore General Hospital
        • Contact:
        • Principal Investigator:
          • Efra Akdas, MSPT(OMPT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both Male and Female age between 40 to 65 years diagnosed with womac ostearthritis index having acute knee pain.
  • Patients with history of osteoarthritis (of grade 1 and 2 with KL(kellgren and Lawerence)) grading system for knee Osteoarthritis
  • Pain in and around knee measuring through Numeric Pain rating Scale(NPRS)>4(14)

Exclusion Criteria:Patient with history of

  • hypertension
  • diabetes
  • sickle cell anemia
  • renal compromise
  • obesity
  • open fracture,
  • increased intracranial pressure
  • pregnancy
  • cancer or tumor,
  • extremity with dialysis access,
  • extremity fracture
  • peripheral vascular compromise
  • DVT(Deep vein thrombosis) & pulmonary embolism deformity of hip & back

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: blood flow restriction training
we will apply blood flow restriction training with low intensity exercises on patients with knee osteoarthritis to check pain,quality of life and range of motion.
Other: blood flow restriction training

we will apply blood flow restriction training with low intensity exercises like knee flexion ,knee extension and straight leg raise 10 repetitions 2 sets a day and 3 times/week a rest interval of 2 minutes between exercises, for 30 minutes of this whole procedure.

total 12 sessions given in 4 weeks each session of maximum 30 minutes
Active Comparator: ultrasound application only
in this group we will apply ultrasound therapy on knee joint for 7 minutes.
Other: ultrasound therapy
All subjects will be given Ultrasound therapy as per patient requirement with 1.5 Watts/cm^2 in continuous mode around knee joint. Conservative exercises(quads isometric exercise, pillow squeeze, heel raise, straight leg raise and side leg raise) will be applied for 3 times per week (daily one set of 10 repetitions) They will be given this treatment for 3 times per week

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NPRS Numeric pain rating scale
Time Frame: 4th week
The NPRS is a self-reported, or clinician administered, measurement tool consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain'. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form. The patient is asked to rate his/her pain intensity and a particular time frame or descriptor is established (e.g. within the last 24 h, today, worst pain, average pain, or least pain)
4th week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Womac index for knee osteoarthritis
Time Frame: 4th week
WOMAC measures three separate dimensions: Pain (5 questions), Stiffness (2 questions), and Pain, stiffness, and physical function were measured by WOMAC. This instrument is validated and recommended by the Osteoarthritis Research Society as the measure of choice when assessing health status in older adults with knee OA. Rating scale ranges from 0 (none) to 4 (extreme), with higher total scores indicating greater dysfunction.The WOMAC addresses symptoms and functional disability in separate scales . Also, the WOMAC is a patient questionnaire.
4th week
Knee Related QOL (QUALITY OF LIFE) Subscale From KOOS
Time Frame: 4th week
The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The effect size is generally largest for the subscale QOL followed by the subscale Pain. The KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis
4th week
Universal goniometer
Time Frame: 4th week
The most common tool for measuring ROM has been the universal goniometer (UG; full-circle manual goniometer. The advantage with the UG is its low cost, but both hands are needed to perform the measurements
4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Iqra Khan, Mphil, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/23/01112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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