Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202005538858076 Date of Approval: 11/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFICACY OF MEDITERRANEAN DIET ON MUSCLE PERFORMANCE IN PATIENTS WITH RHEUMATOID ARTHRITIS: A RANDOMIZED CONTROLLED TRIAL.
Official scientific title Mediterranean diet combined with aerobic and strengthen exercises on the muscle performance, functional ability and fatigue onset of rheumatoid arthritis patients.
Brief summary describing the background and objectives of the trial Rheumatoid arthritis (RA) is a systemic, chronic inflammatory autoimmune disorder affecting approximately 1% of the world population (Gibofsky, 2012). RA may lead to adverse outcomes such as joint function impairment, deformities, muscle shortening, and neurological deficits that affect the patient's performance in daily life activities, (Aletaha et al., 2010). Severe fatigue is common among individuals with RA and has a significant impact on quality of life (Katz, 2017).Muscle performance is an important outcome variable in RA and has to be taken into consideration in patients' care. Relatively little is known about how muscle performance relates to RA clinical variables and muscle performance is not routinely assessed in clinical practice in patients with RA (MAURA et al., 2016). There is a notable body of research pertaining to the Mediterranean diet and there is a paucity of evidence to understand the relationship between this diet and musculoskeletal performance (Jean, 2017).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 30/06/2020
Actual trial start date 25/05/2020
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date 30/12/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mediterranean diet combine with aerobic and strengthen exercise 3 times a week 24 weeks Mediterranean diet: The distribution of macro nutrients was considered as follows: 50% carbohydrates, 30% fats, and 20%proteins. The diet based on the consumption of olive oil or canola oil as the main dietary fat, whole grains (4–6 serving per day), fruits (2–4 serving per day), vegetables (2–3serving per day), fish (2-3serving per week), oil seeds (1–2 serving per day),and legumes (2-4serving per day) (Estruch,.2010) . Patients will visit once per week to ask questions regarding the nutritional regimen and to assess their adherence to the diet. These data were analyzed using the ES-HA Food Processor SQL software. Energy expenditure estimated Basal energy expenditure estimated using Harris and Benedict's equation. 30
Control Group Exercise interventions consisted of aerobic and strengthen exercise patient will receive aerobic exercise 10 minutes treadmill as warm-up 70–89% of maximum heart rate and strengthen exercise for 20 minutes (8–12) repetitions in 2 sets 40% of one repetition maximum (1RM) standardized protocol that included leg-press; knee-extension and seated row use a weight machine, biceps curl, core stability using body weight, and 5 minutes of cooling down. 3 times per week 24 weeks 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The patient's age ranged from 35 to 45 (smolen, 2018). Patient diagnosis of RA from 2 to 3 years ago ( Aletaha etal.,2010). Patient Body mass index 25 kg/m2. Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation. Patients have the ability to follow the diet plan without any health economic restriction. Chronic heart failure, cancer, chronic kidney disease, infection with human immunodeficiency or an autoimmune disease (José et al., 2019). Participants engaged in sport activities, unstable ischemic heart disease or arrhythmia, joint surgery within 6 months prior to inclusion (Elvira et al., 2019) Pregnancy and Diabetic patient Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/04/2020 FACULTY OF PHYSICAL THERAPY APPLICATION FOR ETHICAL REVIEW
Ethics Committee Address
Street address City Postal code Country
7 th elzayat street geza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Biodex system 3 pro Isokinetic dynamometer (Biodex Medical INC., Shirley, New York, USA), It was used to objectively assess factors of muscle performance.Isokinetic knee extension–flexion (concentric–concentric) at 60o/sec used for data collection. before and after completion of the study
Secondary Outcome Assessment of hand grip by hand held dynamometer to assess hand function before and after completion of the study
Secondary Outcome Mediterranean Lifestyle index (MEDLIFE) was developed as a questionnaire to capture adherence to an overall Mediterranean healthy lifestyle. before and after completion of the study
Secondary Outcome The HAQ was developed as a comprehensive measure of outcome in patients with rheumatic diseases. Its focus is on self-reported patient-oriented outcome measures, rather than process measures. There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities before and after completion of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7thelzayat street geza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
rania hakeem 7th el-zayat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university cairo university street geza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ragia mohamed kamil 7 th el zayat street geza 12511 Egypt
Nabil Mahmoud ismail 7 th el zayat street geza 12511 Egypt
Elshaimaa shabaan abd elazem 7 th el zayat street geza 12511 Egypt
dalia Ibrahim tayel 7 th el zayat street geza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator rania hakeem hamed rania.hakeemhamed@gmail.com 01026910533 7th el zayat street
City Postal code Country Position/Affiliation
geza 12511 Egypt assesstant lecturere
Role Name Email Phone Street address
Scientific Enquiries ragia mohamed kamil Ragia.kamil@cu.edu.eg 01222404923 7th el zayat street
City Postal code Country Position/Affiliation
geza 12511 Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Nabil Mahmoud ismail Nabil.mahmoud@cu.edu.eg 01200133613 7th el zayat street
City Postal code Country Position/Affiliation
geza 12511 Egypt Lecturer of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Elshaimaa shabaan abd elazem Shaimaashaaban30@yahoo.com 01033771533 7th el zayat street
City Postal code Country Position/Affiliation
geza 12511 Egypt Lecturer of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries dalia Ibrahim tayel Dalia2tayel@yahoo.com 01223596720 7th el zayat street
City Postal code Country Position/Affiliation
geza 12511 Egypt Professor of nutrition
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the result of the trail 1-muscle performance 2-hand function 3-adherant to diet 4-ADL functional activity Study Protocol 2 years the criteria will be accessed by the publication of trails in international journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information