Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001628831
Ethics application status
Approved
Date submitted
19/12/2019
Date registered
29/11/2021
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of exercises in non-weight positions combined with mobile health on pain, body mass index and exercise adherence in overweight and obese knee osteoarthritis patients: A randomized controlled trial
Scientific title
Effectiveness of rehabilitation protocol in non-weight positions combined with mobile health on pain, body mass index and exercise adherence in overweight and obese knee osteoarthritis patients: A randomized controlled trial
Secondary ID [1] 300142 0
None
Universal Trial Number (UTN)
U1111-1245-0205
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 315670 0
Pain 315671 0
Overweight 315672 0
Exercise adherence 315673 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313962 313962 0 0
Other physical medicine / rehabilitation
Musculoskeletal 314426 314426 0 0
Osteoarthritis
Diet and Nutrition 314845 314845 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will be the lower limb rehabilitation protocol by using mobile health (mHealth). The researcher will allocate selected overweight and obese Knee OA patients into two groups, namely, Group combined with mHealth (Gcw-mHealth), Group without mHealth (Gwo-mHealth). Gcw-mHealth and Gwo-mHealth will perform lower limb rehabilitation exercises at their houses. All groups will be instructed to follow the instructions of daily care. Instructions of daily care are 1. Always prefers to sit than standing. 2. Always walk with a stick. 3. Avoid stair climbing. 4. Do not jog or run as an exercise plan. 5. Always exercise in non-weight bearing positions. e.g sitting or lying positions. 6. Try to reduce your weight by avoiding taking of sugary foods, drinks and high fat foods. Eat mostly plant-based foods. Add omega-3 fatty acids in your daily diet.
Intervention will be delivered by the physiotherapist, who has a ten years experience in the field of therapy and rehabilitation. The physiotherapist will teach the training sessions at the study site and the patients will perform their training sessions at their houses. The participants will perform 45-60 minutes of training sessions 3 times a week for duration of 24 weeks. The training sessions will be performed with an intensity of a load equating to an estimated 50 % of 1RM. The training sessions are strengthening exercises of lower limbs rehabilitation protocol in sitting and lying positions without putting mechanical pressure at the knee. Strengthening exercises will be of muscle groups of hip, knee and ankle joints of lower limbs. The exercise adherence will be checked by the attendance of training sessions completed. Intervention will be delivered by mHealth in the form of periodic manual (by hand not automatic) WhatsApp messages in a WhatsApp group. The researcher will send the two text messages per day for three days a week for a period of 24-weeks to the Gcw-mHealth. The researcher will send the text messages between 7:00 to 9:00 a.m. in the morning and 5:00 to 7:00 p.m. in the evening. The patients will perform the lower limb rehabilitation protocol at their houses. Difference between Gcw-mHealth and Gwo-mHealth is the use of WhatsApp to provide manuals. Periodic manual WhatsApp messages will be send as a reminder only to Gcw-mHealth.
Intervention code [1] 316417 0
Rehabilitation
Intervention code [2] 316765 0
Treatment: Other
Comparator / control treatment
Group without mHealth (Gwo-mHealth)
Gwo-mHealth will perform lower limb Rehabilitation exercises and follow the instructions of daily care at their houses for a duration of 24 weeks. This group will not involve with mHealth application.
Control group
Active

Outcomes
Primary outcome [1] 322372 0
Change in pain.
knee pain will be assessed using a Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Timepoint [1] 322372 0
Baseline evaluation,
12 weeks post-intervention,
&
24 weeks post-intervention
Primary outcome [2] 322373 0
Change in BMI.
Height will be measured by the portable stadiometer and weight by Seca 888 Scale, After measuring height and weight BMI will be calculated using a formula (weight (kg) / height (m2)
Timepoint [2] 322373 0
Baseline evaluation,
12 weeks post-intervention
&
24 weeks post intervention
Secondary outcome [1] 381229 0
Self-reported exercise adherence
Self-reported exercise adherence will be measured by a numerical scale ranging from zero 10. Numerical rating scales from zero to 10 have good validity and reliability and have also been widely used in medical trials
Timepoint [1] 381229 0
12 weeks post-intervention,
&
24 weeks post intervention

Eligibility
Key inclusion criteria
Overweight and obese Knee OA patients
Both males and females
Age between 45 to 60 years
Living in the urban area of Punjab, Lahore, Pakistan
Having OA of one or both knees of grading scale of 2-mild or 3-moderate according to Kellgren and Lawrence radiographic scale (1957)
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Rheumatoid arthritis or system lupus erythematosus (SLE)
Flat feet
Spinal deformities
Participants having history of metabolic, hormonal, orthopaedic, cardiovascular disease Previous surgery of knee/s of any cause
Injections of knee/s for the last six months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Package for Social Sciences (SPSS), version 22, Chicago, IL
Descriptive statistics for the demographic questionnaire and for the mean and standard deviation
Inferential statistics all the quantitative measures
Repeated Measure ANOVA for the overall treatment effects on change in the clinical outcome measures from baseline to post-test assessments in all the continuous outcome data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 22193 0
Pakistan
State/province [1] 22193 0
Punjab

Funding & Sponsors
Funding source category [1] 310166 0
Self funded/Unfunded
Name [1] 310166 0
Country [1] 310166 0
Primary sponsor type
Individual
Name
Mohamad Shariff A Hamid
Address
Sports Medicine Department, University of Malaya Medical Centre, 50603, Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 305231 0
Individual
Name [1] 305231 0
Muhammad Tariq Rafiq
Address [1] 305231 0
1. Rehmatul-Lil-Alameen Postgraduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi Multan Road Lahore, 54000, Pakistan
2. Centre for Sport and Exercise Sciences, University of Malaya, 50603, Kuala Lumpur, Malaysia;
Country [1] 305231 0
Pakistan
Secondary sponsor category [2] 305615 0
Individual
Name [2] 305615 0
Muhammad Irfan Khan
Address [2] 305615 0
Department of Physical Medicine and Rehabilitation,54000, Mayo Hospital Lahore
Country [2] 305615 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305004 0
Ethical Committee Rehmatul-Lil-Alameen Postgraduate Institute of Cardiology, Punjab Employees Social Securiity Institution
Ethics committee address [1] 305004 0
Rehmatul-Lil-Alameen Postgraduate Institute of Cardiology, Punjab Employees Social Securiity Institution, 54000, Multan Road Lahore, Pakistan
Ethics committee country [1] 305004 0
Pakistan
Date submitted for ethics approval [1] 305004 0
26/08/2019
Approval date [1] 305004 0
28/08/2019
Ethics approval number [1] 305004 0
NO.RAIC PESSI/Estt/2019/487

Summary
Brief summary
The participants of Group with mHealth will perform the training sessions lower limb rehabilitation protocol three times a week for 24 weeks at their houses. This 24-weeks treatment protocol will consist of 45–60 minute training session followed by 10 minutes warm up at the start and 10 minutes cool down at the end of training protocol. The reminders to carry out of lower limb rehabilitation protocol and instructions of daily living activities using mHealth in the form of periodic manual WhatsApp messages will be sent to the intervention group.
The strengthening exercises of Lower limb rehabilitation protocol (LLRP) in non weight bearing sitting and lying positions, are recommended as the first line of treatment among knee OA patients who are overweight and obese. The purpose of current study is to investigate the effectiveness of lower limb rehabilitation protocol by using mHealth on pain, BMI and exercise adherence among knee OA patients who are overweight or obese.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98934 0
Dr Mohamad Shariff A Hamid
Address 98934 0
Sports Medicine Department, University of Malaya Medical Centre, 59100, Kuala Lumpur, Malaysia
Country 98934 0
Malaysia
Phone 98934 0
+60379676669
Fax 98934 0
Email 98934 0
[email protected]
Contact person for public queries
Name 98935 0
Dr Muhammad Irfan Khan
Address 98935 0
Department of Physical Medicine and Rehabilitation, Mayo Hospital Lahore
Country 98935 0
Pakistan
Phone 98935 0
+923334323094
Fax 98935 0
Email 98935 0
[email protected]
Contact person for scientific queries
Name 98936 0
Dr Muhammad Tariq Rafiq
Address 98936 0
Rehmatul-Lil-Alameen Postgraduate Institute of Cardiology, Punjab Employees Social Securiity Institution, Multan Chongi, Multan Road Lahore, 54000
Country 98936 0
Pakistan
Phone 98936 0
+923214495948
Fax 98936 0
Email 98936 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
clinical data
When will data be available (start and end dates)?
Data will be available after publication of article.
Available to whom?
Scientists
Available for what types of analyses?
For study purpose
How or where can data be obtained?
The data will be available from the corresponding author upon reasonable request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6246Study protocol  [email protected]
6247Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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