Viewing Study NCT06589960



Ignite Creation Date: 2024-10-26 @ 3:39 PM
Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06589960
Status: COMPLETED
Last Update Posted: None
First Post: 2024-09-06

Brief Title: Effect of Lifestyle Modification on Patients with Knee Osteoarthritis
Sponsor: None
Organization: None

Study Overview

Official Title: Effect of Lifestyle Modification on Patients with Knee Osteoarthritis Attending NRC Rheumatology Clinic
Status: COMPLETED
Status Verified Date: 2022-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: I Pre-intervention was done by

1 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
2 Osteoarthritis Knee and Hip Quality of Life OAKHQOL questionnaire The OAKHQOL is a specific tool to measure QOL in knee and hip OA as it takes into account specific themes that are exclusive to the QOL of patients with knee and hip OA social support sleep side effects of drugs plans for the future embarrassment to be seen by people use of public transport difficulty in moving after staying in the same position and sexuality The concept of this questionnaire was based on the World Health Organization definition of QOL It is a self-administered questionnaire the original questionnaire was developed in French and later in English while in the current study it was translated by the researcher into the 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 Evaluation of the OAKHQOL has shown the reliability of the five domains to be satisfactory interclass correlation coefficients 070-085 the construct validity to be adequate Spearman correlation coefficients 043-075 and the discrimination to be satisfactory Rat et al 2006
3 Western Ontario and McMaster Universities Arthritis Index WOMAC WOMAC is a disease-specific self-administered health status measure that is widely used to assess the symptoms and physical disability for people with knee andor hip OA WOMAC has been translated into more than 65 different languages worldwide in the current study it was translated by the researcher into the Arabic language it has been validated for usage via telephone interviews multimedia with audio-visual presentations verbally spoken computer programs and mobile phone applications It is widely used in OA research especially to monitor the course of the disease or to determine the effectiveness of a variety of interventions pharmacologic surgical physiotherapy etc It provides an excellent look at a patients functional capacity and complements the more objective data provided by magnetic resonance imaging arthroscopy cartilage biopsy and radiographs It consists of 24 items divided into three subscales

Pain 5 items during walking using stairs in bed sitting or lying and standing upright
Stiffness 2 items after first waking and later in the day
Physical Function 17 items using stairs rising from sitting standing bending walking getting in out of a car shopping putting on taking off socks rising from bed lying in bed getting in out of bath sitting getting on off toilet heavy domestic duties light domestic duties

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 0no constraints or difficulties 1 slight 2moderate 3severe 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
4 Knowledge Attitude and Practice KAP questionnaire to identify participants knowledge about OA what is KOA symptoms possible risk factors complications how to delay progression management choices and side effects attitude towards non-surgical interventions and practices nutritional habits physical activity treatment and positions that worsen the condition or protect the knees
5 Clinical assessment the studied participants were subjected to clinical examination and anthropometric measurements body mass index waist and hip circumference
6 Preintervention assessment of concentration of serum biomarker IL-6 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

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

1The researcher provided successful aging topics using PowerPoint presentation mainly about 3 key messages

1 What a regular physical activity and individualized exercise programs can reduce pain prevent worsening and improve daily function in KOA
2 The benefits of losing weight for overweight or obese patients and the benefits of maintaining a healthy weight using diet changes and exercise
3 Treatment of KOA and the fact that its symptoms can often be significantly reduced without the need of undergoing a surgery

2Rheumatologist and physiotherapist also provided messages about the following

What is KOA its risk factors and symptoms how it can vary greatly from person to person and it is not an inevitable part of getting older
Diagnostic methods and how joint damage on an X-ray does not indicate how much your osteoarthritis will affect you
Education about KOA treatment and medication intake its side effects and how important to avoid the overuse of nonsteroidal anti-inflammatory drugs over the long term
How to protect your knees and the movements that should be avoided
A home-based exercise program which was created based on a literature review and consultation of experts aimed to increase lower-limb muscle strength relieve pain and balance In addition it was designed to strengthen the muscles supporting the knee reduce knee stiffness thus reducing stress on the knee joints The program also worked on improving flexibility by stretching these muscles to improve range of motion and prevent injury The exercises targeted the quadriceps hamstrings abductors and adductors as well as both the Gluteus Medius and Gluteus Maximus

Before getting started with the exercises the participants were asked

Always warm up either with knee massage for 5 minutes or 5-10 minutes of low impact activity like walking in place or riding a stationary bicycle
Dont ignore the pain and feel free to ask the researcher if you have any pain while exercising
Ask questions if you are not sure how to do the exercise or how often to do it
Dont ignore stretching after strengthening exercises The program consisted of three groups of exercises each group lasted for two weeks The participants performed the exercises twice daily according to their suitable time but it was preferred early in the morning and before bedtime Once the participant completed the exercises easily and without pain or cramps heshe would go to the next new group of exercises

The 1st group of exercises targeted and strengthened the muscles around the knee especially quadriceps muscle

Isometric quadriceps contraction
Straight leg raises
Lateral leg abduction
Knee flexion in supine position
Seated knee extension The participants started with 2 repetitions for each exercise when the exercises got easier they gradually increased the repetitions till they reached 10 repetitions twice daily

The 2nd group of exercises worked on stretching the muscles of lower limbs

Standing leg extension
Standing hip abduction The main goal in this group of exercises was to gradually increase the time in which the muscle is under tension The participants started with 5 seconds and 2 repetitions for each exercise till they reached 20-30 seconds with 5 repetitions by the end of the two weeks

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

Heel cord stretch
Seated Leg raises
Seated hip abduction
Hamstring curls
Seated leg extension The participants started with 5 seconds and 2 repetitions for each exercise till they reached 20-30 seconds with 5 repetitions by the end of the two weeks

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

3WhatsApp 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

4Phone 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None