NCT06574334

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 25, 2024

Last Update Submit

August 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evaluate the effect of proprioceptive exercises on joint pain among geriatric patients with knee osteoarthritis

    By using Visual Analog Scales (VAS):

    3 months

  • Evaluate the effect of proprioceptive exercises on quality of life among geriatric patients with knee osteoarthritis

    By using 36 - Item Short-Form Health Survey (SF-36).

    3months

Study Arms (2)

The study group received proprioceptive exercises

EXPERIMENTAL

\- 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 control group received routine exercise (Isometric exercise).

EXPERIMENTAL

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

Interventions

* 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.

The study group received proprioceptive exercisesthe control group received routine exercise (Isometric exercise).

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Asyut, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: -Quasi experimental research design was used in this study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 25, 2024

First Posted

August 27, 2024

Study Start

October 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 31, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations