IRCT | Effectiveness of lower limb rehabilitation protocol using mobile health on physical disability and exercise adherence among knee osteoarthritis (OA) patients who are overweight and obese.

Protocol summary

Study aim: The study objective is to investigate the effectiveness of LLRPw-mHeath on physical disability and exercise adherence among knee osteoarthritis patients who are overweight and obese.
Design: A parallel group, single blinded randomized control trial. Sixty participants will be randomly divided into three groups by computer generated numbers. It is a single centered.
Settings and conduct: Study will be conducted at the Teaching Bay of Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology. Participants are blinded in this study. Afetr randomization only one group will be called for their intervention in order to secure the blinding process.
Participants/Inclusion and exclusion criteria: Inclusion criteria Overweight and obese Knee OA patients; Both males and females; Aged between 45 to 60 years; Living in urban area of Punjab, Lahore. Non-inclusion criteria: Rheumatoid arthritis; Flat feet; Spinal deformities; Surgery or injections of knee/s of any cause; System lupus erythematosus (SLE).
Intervention groups: Intervention group 1 (LLRPw-mHeath): The researcher will teach the lower limb rehabilitation protocol by using mHealth and instructions of daily care and will advice them to carry out three times a week for 12-weeks at their houses. The researcher will send the reminder with the mHealth in the form of periodic manual WhatsApp messages two times a day for three days a week for 12 weeks. Intervention group 2 (LLRPwo-mHealth): The researcher will teach the lower limb rehabilitation protocol and instructions of daily care and will advice them to carry out three times a week for 12-weeks at their houses. Control group: The researcher will teach the instructions of daily care to the control group keeping in mind the ethical consideration of patients.
Main outcome variables: Physical disability; Exercise adherence

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20191221045846N1

Registration date: 2020-02-11, 1398/11/22

Registration timing: registered_while_recruiting

Last update: 2020-02-11, 1398/11/22

Update count: 0
Registration date: 2020-02-11, 1398/11/22

Registrant information: Name

Muhammad Tariq Rafiq

Name of organization / entity

Punjab Employees Social Security Institution

Country

Pakistan

Phone

+92 42 99330101

Email address

drtariqrafiq149@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2019-12-25, 1398/10/04
Expected recruitment end date: 2020-03-24, 1399/01/05
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effectiveness of lower limb rehabilitation protocol using mobile health on physical disability and exercise adherence among knee osteoarthritis (OA) patients who are overweight and obese.

Public title: Role of advising exercises using mobile health in treatment of knee osteoarthritis
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Overweight and obese Knee OA patients Both males and females Aged between 45 to 60 years Living in urban area of Punjab, Lahore,

Exclusion criteria:

System lupus erythematosus (SLE) Previous surgery of knee/s of any cause Flat feet Spinal deformities Participants having history of metabolic, hormonal, orthopaedic, cardiovascular diseases The patients who had any injections of knee/s in the last six months.
Age: From 45 years old to 60 years old
Gender: Both

Phase

3

Groups that have been masked

Participant

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

Simple random technique by computer number generator

Blinding (investigator's opinion)

Single blinded

Blinding description

Four research coordinators will be involed in data collection. The two coordinators will be involved in baseline data collection and two coordinators will be invoved in the assessment of outcomes.Participants will be blinded of other group interventions by calling them on different days.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethical Committee Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology, Punjab Employees Soci

Street address

Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road, Lahore, Pakistan

City

Lahore

Postal code

54000
Approval date: 2019-08-28, 1398/06/06
Ethics committee reference number: NO.RAIC PESSI/Estt/2019/487

Health conditions studied

1

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

Primary outcomes

1

Description: Physical disability
Timepoint: Before intervention and 12 weeks after intervention
Method of measurement: Composite Indian Functional Knee Assessment Scale (CIFKAS)

Secondary outcomes

1

Description: Exercise adherence
Timepoint: Before intervention and 12 weeks after intervention
Method of measurement: Numeric rating scale from 0 to 10

Intervention groups

1

Description: Intervention group 1 (LLRPw-mHeath): It will consist of strengthening exercises of the lower limbs in sitting and lying positions and instructions of daily care. The training session of strengthening exercises will be of 30-40 minutes with 10 minutes warm up at the start and 10 minutes cooling down at the end. It will consist of three times a week for 12 weeks at their houses. The reminder in the form of mobile health (periodic manual WhatApp messages) will be send to carry on the training sessions. The messages will be send two times a day for three days a week for a duration of 12-weeks as a reminder.
Category: Other

2

Description: Intervention group 2 (LLRPwo-mHealth): It will consist of strengthening exercises of the lower limbs in sitting and lying positions and instructions of daily care. The training session of strengthening exercises will be of 30-40 minutes with 10 minutes warm up at the start and 10 minutes cooling down at the end. It will consist of three times a week for 12 weeks at their houses. No reminder will be send by using mobile health in this intervention.
Category: Rehabilitation

3

Description: Control group: It will consist of instructions of daily care only as a usual care for duration of 12 weeks at their houses. No reminder will be send by using mobile health in this intervention.
Category: Prevention

Recruitment centers

1

Recruitment center: Name of recruitment center

Teaching Bay of Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology

Full name of responsible person

Dr Farid Ahmad Chaudhary

Street address

Teaching Bay of Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore

City

Lahore

Postal code

54000

Phone

+92 42 99330101

Fax

+92 42 99330098

Email

ms.raic@pessi.gop.pk

1

Sponsor: Name of organization / entity

Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology

Full name of responsible person

Dr Farid Ahmad Chaudhary

Street address

Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore

City

Lahore

Postal code

54000

Phone

+92 42 99330101

Fax

Email

ms.raic@pessi.gop.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore
Proportion provided by this source: 50
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

2

Sponsor: Name of organization / entity

University of Malaya

Full name of responsible person

Dr Eliza Hafiz

Street address

Centre for Sport and Exercise Sciences, University of Malaya, Kuala Lumpur, Malaysia

City

Kuala Lumpur

Postal code

42000

Phone

+60 3-7967 3327

Email

eliza@um.edu.my
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: University of Malaya, Kuala Lumpur, Malaysia
Proportion provided by this source: 50
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

Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology

Full name of responsible person

Muhammad Tariq Rafiq

Position

Consultant Senior Physiotherapist

Latest degree

Medical doctor

Other areas of specialty/work

Physiotherapy

Street address

Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore, Pakistan

City

Lahore

Province

Punjab

Postal code

54000

Phone

+92 42 99330101

Email

drtariqrafiq149@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

University of Malaya

Full name of responsible person

Mohamad Shariff A Hamid

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physical Medicine

Street address

Sports Medicine Department, University of Malaya Medical Centre, Kuala Lumpur, Malaysia

City

Kuala Lumpur

Province

Selangor

Postal code

59100

Phone

+60 3-7967 6669

Email

ayip@um.edu.my

Person responsible for updating data

Contact: Name of organization / entity

Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology

Full name of responsible person

Muhammad Tariq Rafiq

Position

Senior Physiotherapist

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore, Pakistan

City

Lahore

Province

Punjab

Postal code

54000

Phone

+92 42 99330101

Email

drtariqrafiq149@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: Principal investigator doesn't allow.
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Effectiveness of lower limb rehabilitation protocol using mobile health on physical disability and exercise adherence among knee osteoarthritis (OA) patients who are overweight and obese.