IRCT | Developing an 8-week, tele-education weight control and exercise program, and evaluating its effects on weight and pain reduction in patients with obesity and knee osteoarthritis referred to Imam Khomeini Hospital: A ِdouble-blinded randomized clinical trial.

Protocol summary

Study aim: Developing a weight control and exercise program, and evaluating its effect on weight and pain reduction, in patients with obesity and knee osteoarthritis
Design: This study is a Double-Blind Randomized Clinical Trial that is done on 30 participants. For randomization, block randomization will be used.
Settings and conduct: This study is performed in three stages: the first stage includes assessments, the second stage provides education and intervention, and the third stage is the measurement of variables after eight weeks. All stages are performed in the sports medicine department of Imam Khomeini Hospital. In this research, participants, assessor and data analyzer are blinded.
Participants/Inclusion and exclusion criteria: Inclusion criteria included age between 45 and 75 years, BMI between 30 and 50, knee osteoarthritis and no history of bariatric surgery, and no uncontrolled chronic diseases, who have the ability to use the online program. The criteria for not entering the study are pregnancy, the presence of a metal device or pacemaker in the body, recent diet therapy with weight loss, end-stage osteoarthritis, use of weight loss drugs, current intra-articular injections within the last six months and use of physical therapy devices.
Intervention groups: The intervention in this study includes online classes including nutrition, physical activity and Cognitive-behavioral therapy; in addition, a weekly knee exercise program is sent to them for eight weeks. General recommendations for aerobic exercise and weight loss are given to the control group.
Main outcome variables: Age, height, weight, gender, VAS, waist circumference, hip circumference, body composition, KOOS questionnaire, EQ5D questionnaire, G-PAQ questionnaire, use of painkillers, 30 seconds standing up test, TUG test

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20220917055973N1

Registration date: 2022-10-02, 1401/07/10

Registration timing: prospective

Last update: 2022-10-02, 1401/07/10

Update count: 0
Registration date: 2022-10-02, 1401/07/10

Registrant information: Name

Reyhaneh Khazaei

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 6119 2282

Email address

rkhazaei@razi.tums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-10-23, 1401/08/01
Expected recruitment end date: 2023-03-22, 1402/01/02
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Developing an 8-week, tele-education weight control and exercise program, and evaluating its effects on weight and pain reduction in patients with obesity and knee osteoarthritis referred to Imam Khomeini Hospital: A ِdouble-blinded randomized clinical trial.

Public title: Developing an 8-week, tele-education weight control and exercise program, and evaluating its effects on weight and pain reduction in patients with obesity and knee osteoarthritis
Purpose: Education/Guidance
Inclusion/Exclusion criteria: Inclusion criteria:

Age between 45 and 75 years Female or male Radiographic diagnosis of knee osteoarthritis Ability to use the online application No history of bariatric surgery, uncontrolled diabetes, uncontrolled blood pressure, uncontrolled cardiovascular diseases, severe musculoskeletal and neurological disease and any other disease that can limit daily routine activities.

Exclusion criteria:

Getting pregnant Presence of a metal device or heart pacemaker in the body Recent diet therapy with weight loss (5% over 3 months or 10% over 6 months) End-stage osteoarthritis based on the Kellgren and Lawrence classification Use of weight loss medications such as appetite suppressants or any medication that has a significant effect on weight such as steroids. Recent intra-articular injections within the last 6 months Use of physiotherapy devices
Age: From 45 years old to 75 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

In this study, block randomization is used. Thirty participants in this research will be placed in 3 blocks of ten that will be randomly selected by someone other than the researcher. Assigning each of the letters A and B to each of the intervention and control groups is done by a person other than the researcher (a third person).

Blinding (investigator's opinion)

Double blinded

Blinding description

This study is double-blinded. Each candidate is blinded to their group (Intervention or control). The assessor of outcomes, including height, weight, waist circumference, hip circumference, and functional tests is blinded.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Imam Khomeini Hospital Complex - Tehran University of Medical Sciences (Research Ethics Committee)

Street address

Deputy of Research and Technology, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard

City

Tehran

Province

Tehran

Postal code

1419733141
Approval date: 2022-05-21, 1401/02/31
Ethics committee reference number: IR.TUMS.IKHC.REC.1401.037

Health conditions studied

1

Description of health condition studied: knee osteoarthritis
ICD-10 code: M17
ICD-10 code description: Osteoarthritis of knee

Primary outcomes

1

Description: Visual Analogue Scale score
Timepoint: Before the intervention, after eighth weeks
Method of measurement: Using a pain ruler with a scale of 0 to 100

2

Description: Knee Injury and Osteoarthritis Outcome Score
Timepoint: Before the intervention, after eighth weeks
Method of measurement: KOOS questionnaire

3

Description: EuroQol five-dimension scale questionnaire
Timepoint: Before the intervention, after eighth weeks
Method of measurement: EQ5D questionnaire

4

Description: Timed up and go
Timepoint: Before the intervention, after eighth weeks
Method of measurement: Second

5

Description: 30-second Chair Stand
Timepoint: Before the intervention, after eighth weeks
Method of measurement: Counting

6

Description: Body composition analysis
Timepoint: Before the intervention, after eighth weeks
Method of measurement: Body composition analysis

7

Description: Waist circumference
Timepoint: Before the intervention, after eighth weeks
Method of measurement: Meter

8

Description: Hip circumference
Timepoint: Before the intervention, after eighth weeks
Method of measurement: Meter

9

Description: Weight
Timepoint: Before intervention, week 1, week 2, week 3, week 4, week 5, week 6, week 7, end of week 8
Method of measurement: Weighting scale

Secondary outcomes

1

Description: Global physical activity questionnaire
Timepoint: Before the intervention, after eighth weeks
Method of measurement: G-PAQ questionnaire

2

Description: Use of painkillers
Timepoint: Before the intervention, after eighth weeks
Method of measurement: Questionnaire

Intervention groups

1

Description: Intervention group: participating in online training classes includes nutrition, physical activity, and cognitive behavioural therapy (CBT). Also, the knee exercise program including stretch and strength exercises is sent to them based on a weekly schedule for eight weeks.
Category: Lifestyle

2

Description: Control group: one session of educational recommendations on weight loss and aerobic exercise, in addition to the knee exercises for eight weeks.
Category: Lifestyle

Recruitment centers

1

Recruitment center: Name of recruitment center

Imam Khomeini Hospital Complex

Full name of responsible person

Reyhaneh Khazaei

Street address

Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 2281 8672

Email

Reyhanehkh@yahoo.com

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Akbar Fotohi

Street address

Vice chancellor for research and technology, 6th floor, Central building of Tehran University of Medical Sciences, Ghods street, Keshavarz boulevard

City

Tehran

Province

Tehran

Postal code

1417653761

Phone

+98 21 8163 3698

Email

vcr@tums.ac.ir

Web page address

https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Reyhaneh Khazaei

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Sport Medicine

Street address

Department of Sports Medicine, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6119 2282

Email

reyhanehkh@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Zahra Alizadeh

Position

Associate professor

Latest degree

Specialist

Other areas of specialty/work

Sport Medicine

Street address

Department of Sports Medicine, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6658 1637

Email

z_alizadeh@tums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Zahra Alizadeh

Position

Associate professor

Latest degree

Specialist

Other areas of specialty/work

Sport Medicine

Street address

Department of Sports Medicine, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6119 2282

Email

z_alizadeh@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: Initial results and other items at the request of researchers.
When the data will become available and for how long: The period of access starts 6 months after the publication of results.
To whom data/document is available: Please contact this email: z_alizadeh@tums.ac.ir
Under which criteria data/document could be used: Please contact this email: z_alizadeh@tums.ac.ir
From where data/document is obtainable: Please contact this email: z_alizadeh@tums.ac.ir
What processes are involved for a request to access data/document: Please contact this email: z_alizadeh@tums.ac.ir
Comments

Developing an 8-week, tele-education weight control and exercise program, and evaluating its effects on weight and pain reduction in patients with obesity and knee osteoarthritis referred to Imam Khomeini Hospital: A ِdouble-blinded randomized clinical trial.