Protocol summary

Summary
The objective of the present study is to compare aerobic exercise and progressive resistance exercise effect on Knee osteoarthritis. 50 patients, aged 45-70 years old, with knee osteoarthritis participate in this study. The patients were randomized into one of the three groups including control and two intervention groups including aerobic exercise and progressive resistance exercise group. In Aerobic exercise group the patients will walk on a treadmill for 15 minutes that gradually increase to 30 minutes. In progressive resistance exercise group the patients will perform progressive resistance exercise for Hamstring and Quadriceps muscles. In both group the same electrotherapy including Ultrasound, Infrared, and analgesic stimulation was done. Before and after the intervention the pain intensity, quality of life, Range of motion, and walking status will be assessed by VAS, Womac scale, goniameter and 6MWT, respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102114549N3
Registration date: 2011-03-29, 1390/01/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-03-29, 1390/01/09
Registrant information
Name
Elham Fatemy
Name of organization / entity
Semnan University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
fatemy@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between Aerobic exercise and progressive resistance exercise effect on Knee osteoarthritis
Public title
The comparison between Aerobic exercise and progressive resistance exercise effect on Knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 45 to 70 years, Having Physician diagnosed osteoarthritis, Ability to walk at least 15 minutes continuously, Ability to participate in low intensity progressive resistance exercise Exclusion criteria: other form Arthritis, having corticosteroid or viscosupplement injections within the previous three months, history of infection in knee, daily medication for Osteoarthritis, exercising more than 60 minutes per week, musculoskeletal or other diseases that involve knee
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan Universiy of Medical Sciences
Street address
Semnan Universiy of Medical Sciences, 5th Kilometer, Damghan St.
City
Semnan
Postal code
Approval date
2011-01-31, 1389/11/11
Ethics committee reference number
89/47438

Health conditions studied

1

Description of health condition studied
Osteoarthritis
ICD-10 code
M15, M19
ICD-10 code description
Arthrosis

Primary outcomes

1

Description
Walking status
Timepoint
Before and after intervention
Method of measurement
Walking speed by 6MWT

2

Description
Range of motion
Timepoint
Before and after intervention
Method of measurement
The therapist Meatures by guniameter

3

Description
Pain
Timepoint
Before and after intervention
Method of measurement
Interview to patient by VAS

4

Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
Interview to patient by Womac scale

Secondary outcomes

empty

Intervention groups

1

Description
In control group electrotherapy including Infrared,Ultrasound and analgesic current in motor level will be done.
Category
Rehabilitation

2

Description
In aerobic exercise group electrotherapy including Infrared, ultrasound and analgesic current in motor level will be done and then the patients will walk on treadmill for 15 minute.
Category
Rehabilitation

3

Description
In progressive resistance exercise group electrotherapy including Infrared, ultrasound and analgesic current in motor level will be done and then the patients will do progressive resistance exercise for Quadriceps and Hamstring muscles
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy centers of Rehabilitation Facualty of Semnan Universitey of Medical Science
Full name of responsible person
Elham Fatemy
Street address
Semnan Universitey of Medical Sciences
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Vahid Semnany
Street address
Semnan University of Medical Sciences
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Fatemy
Position
MSc-Instructor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4180
Fax
+98 23 1335 4209
Email
fatemyelham@yahoo.com fatemy@sem-ums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Fatemy
Position
Semnan University of Medical Sciences
Other areas of specialty/work
Street address
MSc
City
Semnan University of Medical Sciences
Postal code
Phone
+98 23 1335 4180
Fax
Email
fatemyelham@yahoo.com fatemy@sem-ums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Fatemy
Position
Semnan University of Medical Sciences
Other areas of specialty/work
Street address
MSc-Instructor
City
Semnan University of Medical Sciences
Postal code
3513138111
Phone
+98 23 1335 4180
Fax
+98 23 1335 4209
Email
fatemyelham@yahoo.com fatemy@sem-ums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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