IRCT | Short term effects of strengthening exercises of lower limb rehabilitation protocol (LLRP) on pain, stiffness, physical function and body mass index (BMI) among knee osteoarthritis (OA) participants who are overweight or obese.

Protocol summary

Study aim: To determine the short term effects of strengthening exercises of lower limb rehabilitation protocol on pain, stiffness, physical function and body mass index among knee osteoarthritis participants who are overweight or obese
Design: The study will be single blinded randomized controlled design.Three research coordinators will be involved in data collection. The one coordinator will be involved in baseline data collection and two coordinators will be involved in the assessment of outcomes. Participants will be blinded of other groups intervention.
Settings and conduct: The study will be conducted at the urban area of Lahore Pakistan and measurements will be assessed at the Teaching Bay of Rehmatul-Lil-Alameen Postgraduate Institute
Participants/Inclusion and exclusion criteria: Inclusion Criteria: Overweight or obese knee osteoarthritis participants, age between 45 and 60 years, residing in the urban community of Lahore, second and third degree of knee changes according to Kellgren and Lawrence radio-graphic scale Exclusion Criteria: System lupus erythematosus, Flat feet, Spinal deformities, Participants having history of metabolic, hormonal, orthopaedic and cardiovascular diseases, Previous surgery of knee/s of any cause The patients who had any injections of knee/s in the last six months or Unable to walk independently
Intervention groups: Intervention 1: Intervention group 1 the strengthening exercises of the lower limbs and instructions of daily care. The training session will be of 30-40 minutes. It will consist of three times a week for 4 weeks at their houses. Intervention 2: Intervention group 2 the participants in this group will follow the instructions of daily care only as a usual care for duration of 4 weeks at their houses.
Main outcome variables: Primary: Knee pain, stiffness and physical function Secondary: Patients, s satisfaction and exercise adherence

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20191221045846N2

Registration date: 2020-06-28, 1399/04/08

Registration timing: prospective

Last update: 2020-06-28, 1399/04/08

Update count: 0
Registration date: 2020-06-28, 1399/04/08

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: 2020-07-10, 1399/04/20
Expected recruitment end date: 2020-08-09, 1399/05/19
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Short term effects of strengthening exercises of lower limb rehabilitation protocol (LLRP) on pain, stiffness, physical function and body mass index (BMI) among knee osteoarthritis (OA) participants who are overweight or obese.

Public title: Short term effects of exercises among knee osteoarthritis (OA) participants who are overweight or obese.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Overweight or obese knee OA participants aged between 45 to 60 years. Familiar with WhatsApp application Participants will be chosen from the urban area community of Punjab Lahore, Pakistan. The sample included males and females having OA of one or both knees confirmed by medical specialist according to the Kellgren and Lawrence radiographic scale for the assessment of OA

Exclusion criteria:

Rheumatoid arthritis System lupus erythematosus Flat feet Spinal deformities Unable to walk independently History of metabolic, hormonal, orthopaedic or cardiovascular disease Previous surgery of knee/s Injections of knee/s for the last six months.
Age: From 45 years old to 60 years old
Gender: Both

Phase

2

Groups that have been masked

Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Randomized

Randomization description

The researcher will allocate the selected knee osteoarthritis participants into two groups, namely, Rehabilitation Protocol Group (RPG) and Control Group (CG) by simple random technique using a computer-generated random number. The participants in the RPG will follow the strengthening exercise of LLRP and IDC for duration of 4-weeks. The participants in the CG will not involved in the rehabilitation protocols, but these participants will follow only the IDC for the duration of 4-weeks at their houses.

Blinding (investigator's opinion)

Single blinded

Blinding description

The principle investigator will not be blinded. The participants receiving the intervention will be blinded by simply not informing them of their treatment allocation. The coordinators collecting data will be independent individuals from trials and will be unaware of the group allocation. There will be different coordinators at the initial and final evaluation. Individuals performing the statistical analysis will be blinded by labelling the groups with non-identifying terms (such as X and Y).

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethical Committee RAIC PESSI (Rehmatul-Lil-Alameen Postgraduate Institute of Cardiology, Punjab Empl

Street address

Multan Chongi Multan Road Lahore,

City

Lahore

Postal code

54000
Approval date: 2020-05-20, 1399/02/31
Ethics committee reference number: RAIC PESSI/Estt/2020/36

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: knee pain
Timepoint: at baseline and after 4 weeks of intervention
Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

2

Description: Stiffness
Timepoint: At baseline and after 4 weeks of intervention
Method of measurement: WOMAC score

3

Description: Physical function
Timepoint: At baseline and after 4 weeks of intervention
Method of measurement: WOMAC score

Secondary outcomes

1

Description: Body Mass Index
Timepoint: At baseline and after 4 weeks of intervention
Method of measurement: Calculated by the formula Weight (kg)/Height(meter square)

2

Description: Patients satisfaction
Timepoint: After 4 weeks of intervention
Method of measurement: Numeric rating scale ranging from 0 to 10

3

Description: Exercise adherence
Timepoint: After 4 weeks of intervention
Method of measurement: Numeric rating scale ranging from 0 to 10

Intervention groups

1

Description: The participants in this group (Rehabilitation Protocol Group) will perform the strengthening exercises of lower limb rehabilitation protocol (LLRP) and follow the instructions of daily care (IDC) for duration of four weeks at their houses according to the provided leaflet. Each training session of strengthening exercises will be performed three times a week for four weeks at their houses. These training sessions were the strengthening exercises of lower limbs in non-weight bearing sitting and lying positions. Each training session will consist of 45–60 minutes of training followed by 10 minutes warm up at the start and 10 minutes cool down at the end of training protocol.
Category: Treatment - Other

2

Description: The participants in this group (Control Group) will follow only the instructions of daily care (IDC) for duration of four weeks at their houses according to the provided leaflet.
Category: Treatment - Other

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?: Yes
Title of funding source: Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology
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: Other

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: N/A
Proportion provided by this source: 50
Public or private sector: Public
Domestic or foreign origin: Foreign
Category of foreign source of funding: Sponsor: country of origin
Country of origin: PK
Type of organization providing the funding: Other

Person responsible for general inquiries

Contact: Name of organization / entity

Punjab Employees Social Security Institution

Full name of responsible person

Muhammad Tariq Rafiq

Position

Consultant Senior Physiotherapist

Latest degree

Medical doctor

Other areas of specialty/work

Physiotherapy

Street address

54000 B. Rehmatul-Lil-Alamine Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore

City

Lahore

Province

Punjab

Postal code

54000

Phone

+92 42 99330101

Fax

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

Punjab Employees Social Security Institution

Full name of responsible person

Muhammad Tariq Rafiq

Position

Consultant Senior Physiotherapist

Latest degree

Medical doctor

Other areas of specialty/work

Physiotherapy

Street address

54000 B. Rehmatul-Lil-Alamine Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore

City

Lahore

Province

Punjab

Postal code

54000

Phone

+92 42 99330101

Fax

Email

drtariqrafiq149@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be 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: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be 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: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Short term effects of strengthening exercises of lower limb rehabilitation protocol (LLRP) on pain, stiffness, physical function and body mass index (BMI) among knee osteoarthritis (OA) participants who are overweight or obese.