National Research Centre
Cairo, Cairo Governorate, 12622, Egypt
NCT Number: NCT06589960
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.
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Notify Me36 year–70 year
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 12622, Egypt
I) Pre-intervention was done by:
The Index is available in 5-point Likert (LK), 100mm visual analog (VA), and 11-point numerical rating (NR) scaling formats. On the Likert scale, each question had five alternatives 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.
II) Health Education program Implementation: Nine educational sessions were held. In each session, 10-15 participants attended with total number of 109 participants. The session took 120 minutes.
1.The researcher provided successful aging topics using PowerPoint presentation mainly about 3 key messages:
2.Rheumatologist and physiotherapist also provided messages about the following:
Before getting started with the exercises the participants were asked:
The 1st group of exercises targeted and strengthened the muscles around the knee especially quadriceps muscle:
The 2nd group of exercises worked on stretching the muscles of lower limbs
The 3rd group: The exercises worked on stretching and increasing the range of motion of front and back lower limb muscles (quadriceps muscle, hamstring muscle, gluteus muscle and calf muscles):
During the sessions, all the previous exercises were shown to the participants by a colleague and video recorded as well.
The researcher with the help of the supervisors designed an Educational Booklet after identifying the needs of the studied patients according to baseline health assessment. The booklet included information about osteoarthritis, risk factors, symptoms, diagnostic methods, how to delay its progression, healthy nutrition, importance of weight control and its influences, management of knee OA, physical activities, and home-based exercises with pictures of how to perform it. The booklet was distributed to the participants during the sessions.
3.WhatsApp groups were created for each group of exercises. Through each group, messages were distributed to summarize the content of the booklet. This is an easily accessible way to help them to follow the health education modifications and to keep them motivated to perform the home exercises every day, and to motivate each other. Exercises videos which were taped during the sessions were also sent in the group to remind them how to do each exercise correctly guided with the explanation in the booklet. This group also made it easier to the participants to contact the research team whenever they had any inquiry concerning exercises, lifestyle modifications.
4.Phone calls to follow up the participants and maximize their adherence to the health education program were done.
III) Post-intervention evaluation:
After six months of follow-up, this stage was carried out using WOMAC, OAKHQOL questionnaire, and KAP questionnaire to assess the effect of health education and lifestyle modification on the participants. Additionally, it was done to assess the activity, level of movement] and the degree of pain. Among the 104 participants who attended the health education sessions and finished the home exercise program, only 84 participants were able to fill the post-intervention questionnaires.
In the pre intervention, the mean scores of Il-6 for all participants were within normal (single and total), so there was no benefit of repeating it in the post intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
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.
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 6 months
Knowledge, Attitude and Practice (KAP) questionnaire to identify attitude towards non-surgical interventions.
Time frame: 6 months
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.
Time frame: 2 months
Sociodemographic questionnaire: to gather information regarding participants age, gender, marital status, occupation, level of education, smoking habits, duration of the disease, medical history, and medications taken.
Time frame: 2 months
The studied participants were subjected to clinical examination and anthropometric measurements (body mass index, waist and hip circumference)
Time frame: 2 months
The studied participants were subjected to anthropometric measurements as waist circumference
Time frame: 2 months
The studied participants were subjected to anthropometric measurements as hip circumference
Time frame: 2 months
This assessment was done on a sub sample of studied participants (n=76). A blood sample of 3cm was collected from all the participants after 12- hours fasting (to avoid the inflammatory effect of food) to measure inflammatory biomarkers (IL-6). This assessment was done on a sub sample of participants according to certain circumstances (as not receiving anti-inflammatory drugs in in the past 3 months and those who were adherent to the program of health education).
Time frame: 2 months
The studied participants were subjected to anthropometric measurements as body mass index by measuring Weight and Height
National Research Centre, Egypt
Other
Effect of Lifestyle Modification on Patients with Knee Osteoarthritis Attending NRC Rheumatology Clinic
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