Proprioceptive Exercises on Joint Pain and QoL Among Geriatric Patients With Knee Osteoarthritis

August 25, 2024 updated by: Aml Hamdi Mahmoud, Assiut University

Effect of Proprioceptive Exercises on Joint Pain and Quality of Life Among Geriatric Patients With Knee Osteoarthritis

Knee osteoarthritis, the disease of knee joint pain caused by joint degeneration, it is the commonest joint disease and had a negative effect on geriatric patients' quality of life (QoL). Proprioceptive exercise and isometric exercise have been recommended as suitable for reducing joint pain and improvement of quality of life in the geriatric patients.

Study Overview

Status

Status

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

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

Knee osteoarthritis (OA), known as degenerative joint disease of the knee. It is most common in the geriatric and is typically the result of wear and tear and progressive loss of articular cartilage. It happens when cartilage in knee joint breaks down. When this happens, the bones in knee joint rub together, causing friction that makes knees hurt, become stiff or swell. Knee OA is a painful condition and causes exhaustion in affected patients. Patients with this illness often complain of pain, decreased muscle strength, and joint instability. In addition, increased pain in knee OA patients also progressively worsen their quality-of-life. Proprioceptive activity in patients with knee OA gets limited or reduced and leads to reduced activities of daily living (ADLs). Joint proprioception is the ability of an individual to sense the joint position and movement. It encompasses the joint motion and joint position so proprioceptive exercises are being used for the strengthening of muscles around the knee joint. Thus, proprioceptive exercises are recommended exercise which significantly improved pain in knee OA patients which as results lead to improve quality of life. Quadriceps strengthening has been an important component of exercise program of knee osteoarthritis. This is because quadriceps weakness is the most presented finding among people with knee osteoarthritis. An isometric exercise is a form of exercise involving the static contraction of a muscle without any visible movement in the angle of the joint which lead to reduce joint pain and improving QoL in geriatric patients with knee osteoarthritis. The study sample (70) geriatric patients received proprioceptive exercises only, while the control group (70) geriatric patients received routine exercise (Isometric exercise) only.

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 (Actual)

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.
140

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 Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of nursing

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:

  • Geriatric patients aged 60 years and above diagnosed with knee OA.
  • Male and female geriatric patients.
  • Alert and able to communicate.
  • Mild and moderate knee OA (based on X-rays)

Exclusion criteria:

  • Patients with advanced knee OA.
  • Patients with end stage organ failure.
  • Patients with cognitive impairment who will not be able to take active part in the study.
  • Patients with neurological impairment or physical disability that interfere with their participation in the study.
  • Patients with uncontrolled medical conditions.

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: Other
  • 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: The study group received proprioceptive exercises
- The study group included education about definition, components and benefits of proprioceptive exercises for geriatric patients with knee osteoarthritis in the first week. Also, was including proprioceptive exercises that included; One-leg balance, Toe walking, Heel walking, Cross-body leg swings, Blind advanced one leg balance and instructed them to do these 5 exercises (15-20 repetitions of each) per session, 5 day a week.
Procedure: Proprioceptive exercise
  • The first session was included an orientation to the exercises and its purpose to geriatric participants in the first week. Also, pretest was done in the first session before implementing exercises to assess geriatric KOA pain and QOL, each session started by revision about what was given during the previous session and the objectives of the next session.
  • The 2nd session about exercises.
  • The 3rd session for repetition of exercises to ensure that the patient has learned it well in the second week.
  • The 4th session after six weeks later (from wk. (3) to wk. (8) to make posttest after implementation session.
  • The 5th session after two-month later (from wk. (9) to wk. (16) to do follow up test.
Experimental: the control group received routine exercise (Isometric exercise).
the control group included education about definition, benefits and steps of isometric exercise that included participants taking the long sitting position. A role of towel was placed below the affected knee. The participants were then asked to press the towel down and hold it to one minute and then relax. This was repeated again for the other knee and (10-15 repetitions) per session, 5 day a week.
Procedure: Proprioceptive exercise
  • The first session was included an orientation to the exercises and its purpose to geriatric participants in the first week. Also, pretest was done in the first session before implementing exercises to assess geriatric KOA pain and QOL, each session started by revision about what was given during the previous session and the objectives of the next session.
  • The 2nd session about exercises.
  • The 3rd session for repetition of exercises to ensure that the patient has learned it well in the second week.
  • The 4th session after six weeks later (from wk. (3) to wk. (8) to make posttest after implementation session.
  • The 5th session after two-month later (from wk. (9) to wk. (16) to do follow up test.

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
Evaluate the effect of proprioceptive exercises on joint pain among geriatric patients with knee osteoarthritis
Time Frame: 3 months
By using Visual Analog Scales (VAS):
3 months
Evaluate the effect of proprioceptive exercises on quality of life among geriatric patients with knee osteoarthritis
Time Frame: 3months
By using 36 - Item Short-Form Health Survey (SF-36).
3months

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.
Assiut University

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.
October 1, 2023

Primary Completion (Actual)

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.
May 1, 2024

Study Completion (Actual)

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.
May 31, 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).
August 25, 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.
August 25, 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.
August 27, 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.
August 27, 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.
August 25, 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.
August 1, 2024

More Information

Terms related to this study

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.
  • KOA Geriatric

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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