The aim of this study is to investigate the effectiveness of progressive resistance strengthening training on body mass index, quality of life and functional capacity in the overweight and obese knee osteoarthritis patients.
Design
Study will be single-blinded randomized controlled design
Settings and conduct
Study will be conducted at the Teaching Bay of Rehmatul-Lil-Alameen Postgraduate institute of cardiology, Punjab Employees Social Security Institution. The principle investigator will not be blinded. The participants receiving the intervention will be blinded by simply not informing them of their treatment allocation.
Participants/Inclusion and exclusion criteria
The inclusion criteria will be: (1) Overweight and obese knee osteoarthritis patients having osteoarthritis of one or both knees (2) Osteoarthritis grading scale of 2-mild or 3-moderate according to Kellgren and Lawrence radiographic scale (3) Symptoms of osteoarthritis for more than three months (5) Residing in the Urban community of Lahore .
Exclusion criteria will be one or more of the following: (1) Flat feet (2) Knee surgery (3) Corticosteroid injection of knee (4) Spinal deformities (5) Cardiac problem or (6) Hormonal problem
Intervention groups
Intervention groups will be Rehabilitation Protocol Group and the Control Group. The patients in the Rehabilitation Protocol Group will perform the progressive resistance strengthening training in non-weight bearing sitting and lying positions following the instructions of daily care for duration of 12-weeks. The patients in the Control Group will follow the instructions of daily care for duration of 12-weeks.
Main outcome variables
Primary outcome measures will be body mass index and quality of life. Secondary outcome measure will be the functional capacity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191221045846N3
Registration date:2020-07-20, 1399/04/30
Registration timing:registered_while_recruiting
Last update:2020-07-20, 1399/04/30
Update count:0
Registration date
2020-07-20, 1399/04/30
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
2020-07-16, 1399/04/26
Expected recruitment end date
2020-10-15, 1399/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of progressive resistance strength training on body mass index, quality of life and functional capacity in knee osteoarthritis
Public title
The role of strength training in treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight and obese knee osteoarthritis patients having osteoarthritis of one or both knees
Osteoarthritis grading scale of 2-mild or 3-moderate according to Kellgren and Lawrence radiographic scale
Symptoms of osteoarthritis for more than three months
Residing in the Urban community of Lahore
Exclusion criteria:
Flat feet
Knee surgery
Corticosteroid injection of knee
Spinal deformities
Cardiac problem
Hormonal problem.
Age
From 45 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The study will be single blinded randomized controlled design. The method of allocation generation will be done by a computerized random-number generator. The sequence will be generated by the process of simple randomization. Simple randomization will be based on a single sequence of random assignments.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.
Blinding (investigator's opinion)
Single blinded
Blinding description
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
2020-03-30, 1399/01/11
Ethics committee reference number
RAIC PESSI/Estt/2020/2419
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Body Mass Index
Timepoint
At pre-test and post-test (after 12-weeks of intervention) measurements
Method of measurement
Calculated by the formula Weight (kg)/Height(meter square)
2
Description
Quality of life
Timepoint
At pre-test and post-test (after 12-weeks of intervention) measurements
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index summary score of pain, stiffness and physical function
Secondary outcomes
1
Description
Functional capacity
Timepoint
At pre-test and post-test (after 12-weeks of intervention) measurements
Method of measurement
Gait Speed Test will be used for the assessment of functional capacity
Intervention groups
1
Description
Intervention group: The participants in the intervention group will perform the training sessions of progressive resistance strength training of lower limb muscle groups following the instructions of daily care for duration of 12-weeks. Each training session started with 10 minutes warm up, 45–60 minutes of progressive resistance strength training of lower limb muscle group,s training, and 10 minutes cool down at the end of training session.
Category
Treatment - Other
2
Description
Control group: The participants in the control group will follow the instructions of daily care for duration of 12-weeks. Instructions of daily care are general guidelines of eating and care of knee in order to prevent the cartilage destruction.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Teaching Bay of Rehmatul-Lil-Alameene Post Graduate Institute
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
Email
ms.raic@pessi.gop.pk
Sponsors / Funding sources
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
Email
ms.raic@pessi.gop.pk
Grant name
N/A
Grant code / Reference number
N/A
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
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
Mohamad Shariff A Hamid
Street address
Sports Medicine University Malaya Medical Centre, Kuala Lumpur, Malaysia
City
Kuala Lumpur
Postal code
59100
Phone
+60 3-7949 8065
Email
ayip@um.edu.my
Grant name
N/A
Grant code / Reference number
N/A
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
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 99330103
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
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