Effect of Lifestyle Modification on Patients with Knee Osteoarthritis

NCT06589960 | Completed

• 1 other identifier: 8/4/7
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cross-sectional study carried out on 180 Knee osteoarthritis (KOA) patients who were consecutively recruited from the Rheumatology Outpatient Clinic at National Research Center (NRC), Egypt. A face-to-face interview was carried out to collect data about demographic data, medical history, and Knowledge, Attitude and Practice (KAP). Assessment of symptoms, disease severity, and physical disability was carried out using Western Ontario and McMaster Universities Arthritis Index (WOMAC). Quality of life was also assessed using Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) questionnaire. The studied participants were subjected to clinical examination and anthropometric measurements and a blood sample was collected from them to measure inflammatory biomarkers Interleukin-6 (IL-6). Then a health education and physical exercise were done. An Educational Booklet was designed and distributed to the studied patients. WOMAC, OAKHQOL, and KAP questionnaires were used to assess the effect of health education and lifestyle modification on the participants.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Lifestyle; Modification; WOMAC

Outcome Measures

Primary Outcomes (5)

• Assess the symptoms and physical disability, monitor the course of KOA, and determine the effectiveness of a variety of interventions

  A Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a disease-specific, self-administered health status measure that is widely used. In the current study, WOMAC was translated by the researcher into the Arabic language. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), physical Function (17 items). The Index is available in 5-point Likert (LK), where 0=no constraints or difficulties, 1=slight, 2=moderate, 3=severe, 4= extreme. The highest score for each subscale on WOMAC on the Likert scale was 20 for pain, 8 for stiffness and 68 for physical function. The highest total score (96) denotes worse or more symptoms and the strongest physical constraints.

  6 months

• Measure QOL in KOA and assess the effect of health education and lifestyle modification

  An Osteoarthritis Knee and Hip Quality of Life questionnaire (OAKHQOL) is a specific tool. In the current study, it was translated by the researcher into Arabic language. It has 43 items which fall into five domains: physical activity (16 items), mental health (13 items), pain (4 items), social support (4 items), social functioning (3 items), and three items are independent. Response to all items is by a Numerical Rating Scale (NRS) (0-10). A total score for each subscale is calculated by averaging the values for items of the same dimension and is normalized to a score from 0 (worst HRQOL) to 100 (best HRQOL).

  6 months

• Identify knowledge about KOA

  Knowledge, Attitude and Practice (KAP) questionnaire to identify participants' knowledge about KOA: what is KOA, symptoms, possible risk factors, complications, how to delay progression, management choices, and side effects.

  6 months

• Identify attitude about KOA

  Knowledge, Attitude and Practice (KAP) questionnaire to identify attitude towards non-surgical interventions.

  6 months

• Identify practices about KOA

  Knowledge, Attitude and Practice (KAP) questionnaire to identify practices: (nutritional habits, physical activity, treatment, and positions that worsen the condition or protect the knees) and to assess the effect of health education and lifestyle modification on the participants.

  6 months

Secondary Outcomes (6)

• Sociodemographic data

  2 months

• Clinical assessment

  2 months

• Measuring waist circumference

  2 months

• Measuring hip circumference

  2 months

• Serum IL-6 concentration assessment

  2 months

Study Arms (1)

Intervention

EXPERIMENTAL

* Health education * Physical exercise

Combination Product: Health education and physical exercise

Interventions

Health education and physical exercise COMBINATION_PRODUCT

Nine face to face sessions and group discussion health education sessions. An Educational booklet was prepared and distributed to all attendants. Lab results were discussed individually with each participant. Rheumatologist and physiotherapist also provided messages. The exercise program targeted and strengthened the muscles around the knee especially quadriceps muscle, stretching the muscles of lower limbs, and stretching and increasing the range of motion of front and back lower limb muscles (quadriceps muscle, hamstring muscle, gluteus muscle and calf muscles). Phone calls to follow up the participants and maximize their adherence to the health education program. WhatsApp groups was created, and messages were distributed to summarize the content of the booklet and the exercises videos. Final reassessment to assess the effect of health education and lifestyle modification was carried out with participants who continued till the end of the study.

Intervention

Eligibility Criteria

• Age: 36 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• KOA patients from both sexes.
• Age above 35 years old.
• One/both knee joint affection.

You may not qualify if:

• Other causes than OA for joint problems (e.g. hip fracture, chronic widespread pain, acute inflammatory joint disease, or cancer).
• Patients receiving physical therapy or intra-articular injection in the past 3 months.
• Total joint replacement or other surgery of the knee or hip within the past 3 months.
• Immunosuppressant intake in the past 3 months.
• Pregnancy, end stage disease or malignancy.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Cairo, Cairo Governorate, 12622, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: March 1, 2022
• Primary Completion: June 15, 2022
• Study Completion: October 15, 2022
• Last Updated: September 24, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)