Comparison of the short-term effects of clinically supervised and Internet-based exercise therapy on pain, range of motion, and function in patients with knee osteoarthritis: a randomized clinical trial.
Comparison of Short-Term Effects of Clinically Supervised and Internet-Based Exercise Therapy on Pain, Movement Range, and Performance in Patients with Knee Osteoarthritis.
Design
First, an overview of the study is presented for the participants, then the research checklist, which contains questions about demographic information and the medical history, as well as questions about the intensity of knee pain, is completed by the researcher. Then, other clinical and functional assessments will be carried out.
Settings and conduct
Hazrat Rasool Akram Hospital-Sports Medicine Clinic
Participants/Inclusion and exclusion criteria
Participants included of women aged 50 to 75 years old with primary osteoarthritis of the knee were randomly assigned to one of two groups: Internet-based Exercise Therapy (intervention group) or Supervised Exercise Therapy (control group).
Pain, Knee range of motion, Thigh girth, Physical function.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101228005486N8
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Azar Moezy
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
moeziazr@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-15, 1400/02/25
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the short-term effects of clinically supervised and Internet-based exercise therapy on pain, range of motion, and function in patients with knee osteoarthritis: a randomized clinical trial.
Public title
Therapeutic exercise in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary OA of the knee joint grade 2, 3 according Kellgren and Lawrence scale;
ّFemale gender;
Age between 50-75;
Knee pain for at least six months and with intensity 4 on the VAS scale in activities such as going up and down stairs, sitting and squat;
Normal mental state;
Ability to walk independently for at least 30 meters
BMI equal or less than 30;
Patient's consent to participate in the research;
Familiarity how to use the Internet and social media for the Internet-based Exercise Therapy (IET) group.
Exclusion criteria:
History of knee intra-articular injection in the past six months;
History of neuromuscular disease;
History of knee traumatic injuries approved by the physician;
History of lower limb surgery during the last year;
Bone implants,
History of new fractures in lower limbs;
Malignant tumors;
Participating in exercise therapy and physical therapy programs in the recent three months;
History of chronic disease or any conditions that known to affect the study;
Age
From 50 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Restricted Randomization method of Block Randomization will be used to ensure that the number of samples allocated to each of the study groups is equal. Random Allocation Software (Latest Version) will also be used as a randomization tool; it is free to use for academic study and can be found at: http://www.msaghaei.com/Softwares/dnld/RA.zip. This software, in addition to simple randomization, will produce random sequences using the blocking method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the assessor will be blinded to the study groups. The outcomes will be evaluated pre and post intervention by a sports medicine assistant who will be blind to the presence of patients in the groups.
Furthermore, the data obtained from the study will be analyzed by a statistician who is not aware of the patient groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University Of Medical Sciences, Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.IUMS.FMD.REC.1399.628
Health conditions studied
1
Description of health condition studied
Primary knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
Pre- and post-intervention
Method of measurement
VAS pain scale
2
Description
Active knee range of flexion
Timepoint
Pre- and post-intervention
Method of measurement
Goniometery
3
Description
Thigh girth
Timepoint
Pre- and post-intervention
Method of measurement
With centimeter tape
Secondary outcomes
1
Description
Functional Tests
Timepoint
Pre- and post-intervention
Method of measurement
Timed Up & Go Test and Six-Minute Walk Test
Intervention groups
1
Description
Intervention group: Internet-based Exercise Therapy(IET) group-First, Internet connectivity and instant message systems will be examined for patients in the Internet-based exercise therapy group. In this study, an exercise therapy manual is prepared for the IET group, along with pictures of how to perform the exercise, and it will be given to them the day before the intervention, and they will be asked to follow their exercise therapy protocol similar to the control group and to exercise three times a week for six weeks (a total of 18 sessions). The researcher has used the messenger application to create an Internet group for IET group patients, where they would be able to get information about osteoarthritis of the knee, the procedure of exercise training, and general advice in the form of pictures and animations. This approach allows patients to share their feelings about the disease, symptoms, and exercise treatment, as well as communicate ideas about it. This, of course, would allow patients to continue with their exercise therapy. Furthermore, brief tutorial videos about doing exercise protocols will be prepared and submitted to each patient separately via the messaging application, and if the patient has any questions about doing exercises, she will use the video call choice to learn how to do exercises online or be monitored online and receive sufficient verbal and visual input to execute the correct exercises. Moreover, to ensure the exercise is performed, the researcher calls the patient and a close relative who stays with her on three pre-arranged days and asks questions about how the patient workouts and responds and record them in a logbook that will be prepared for each patient. The exercise protocol for patients with knee osteoarthritis in this study is the same for all participants in both the intervention and control groups, and it includes strengthening exercises to improve thigh muscle strength and stretching exercises to increase the flexibility of the soft tissues around the joint and increase the range of motion. Some exercises have been designed based on the findings of numerous research to enhance the function and coordination of the patients.
Category
Rehabilitation
2
Description
Control group: Supervised Exercise Therapy (SET)-Patients in the exercise therapy group will be supervised by a physical medicine assistant at sports medicine clinic for six weeks, alternating three days per week, for a total of 18 sessions under an exercise therapy protocol similar to the IET group. It is worth noting that all exercises will be done in the same protocol for both lower limbs. In the SET group, as in the intervention group, the same questions are asked about how the patient completes exercises and reacts, and this detail is recorded in a logbook that is personalized for each patient. The exercise protocol for patients with knee osteoarthritis in this study is the same for all participants in both the intervention and control groups, and it includes strengthening exercises to improve thigh muscle strength and stretching exercises to increase the flexibility of the soft tissues around the joint and increase the range of motion. Some exercises have been designed based on the findings of numerous research to enhance the function and coordination of the patients.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is 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
A portion of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
One year after the publication of articles related to the research project
To whom data/document is available
Researchers and specialists working in universities and health centers
Under which criteria data/document could be used
Analysis on the data delivered after obtaining permission from the researchers
From where data/document is obtainable
Dr Azar Moezy -Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh St, Sattarkhan Ave, Zip code:14455613131,Tehran.
What processes are involved for a request to access data/document
The applicant of the data file should send a request to the researcher via email and the researcher will notify the applicant after negotiating with other research colleagues, and this procedure will take a period of one month.