Comparison of the Immediate Effect of Supplementary Cycle Ergometery and Treadmill Walking Exercise with Conventional Physical therapy on the Pain and Function in Patients with Moderate Knee Osteoarthritis
This study wants to compare the effects of cycle ergometery and treadmill walking with conventional physical therapy. Participants with one or both knee pain on most days of the previous month occurring during weight-bearing activities and demonstrated radiographic changes; K-L grades of 2; At least 90 degree of knee range of motion; Age between 40-70 years and stable baseline blood pressure according to the American College of Sports Medicine guidelines for exercise will be included in the study. Participants with severe patellofemoral pain and cardiovascular disease and participants that be unable to walk on a treadmill will be excluded from the study.30 participants with moderate knee OA will be divided to three subgroups include treadmill training group, cycle ergometer group and control group. Subjects will start attending Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences three times a week, for 10 sessions. The conventional physical therapy will take 40 minutes and treadmill training or cycle ergometer will take 17 minutes separately.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015013120888N1
Registration date:2015-11-27, 1394/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-27, 1394/09/06
Registrant information
Name
Zahra Sadat Rezaeian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5042
Email address
zrezaeian@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Vice Chancellor of Research and Technology
Expected recruitment start date
2015-02-02, 1393/11/13
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Immediate Effect of Supplementary Cycle Ergometery and Treadmill Walking Exercise with Conventional Physical therapy on the Pain and Function in Patients with Moderate Knee Osteoarthritis
Public title
Comparison of the Immediate Effect of Supplementary Cycle Ergometery and Treadmill Walking Exercise with Conventional Physical therapy on the Pain and Function in Patients with Moderate Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: One or both knee pain on most days of the previous month occurring during weight-bearing activities and demonstrated radiographic changes; Patients with K-L grades of 2;At least 90 degree of knee range of motion; Age between 40-70 years; Stable baseline blood pressure according to the American College of Sports Medicine guidelines for exercise
Exclusion criteria: Serious medical conditions for which exercise will be contraindicated; Severe patellofemoral pain that will not allow participation in the stationary cycling regimen; Be unable to walk on a treadmill without an assistive device; Any cardiovascular disease as uncontrolled hypertension or unstable angina or neurological disorder (i.e. stroke, Parkinson’s, etc.) that can affect patient gait in various forms; Presence of clinical symptoms of OA in hip, ankle or foot; Any significant foot disease that cause change in gait
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences, Ethics Committee
Street address
Hezar Jarib Ave, Isfahan University of Medical Sciences
City
Isfahan
Postal code
81745-164
Approval date
2015-02-01, 1393/11/12
Ethics committee reference number
193079
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
Pain
Timepoint
A day before starting the study and a day after the last exercise session
Method of measurement
VAS
2
Description
Function
Timepoint
A day before starting the study and a day after the last exercise session
Method of measurement
Koos, TUG, 6 min Walking Test
Secondary outcomes
1
Description
Cardovascular Fitness
Timepoint
A day before starting the study and a day after the last exercise session
Method of measurement
Bruce test
Intervention groups
1
Description
a. Tests and control groups will undergo a conventional physical therapy program of three sessions a week for ten sessions. Each session will take 40 minutes.Conventional physical therapy includes:1. Acupuncture TENS (low rate): 2-10 HZ, 200-300 microsecond, 20-30 minutes, four electrodes over the superior and inferior medial and lateral poles of the patella 2.Hot moist pack for 20 minute 3.Ultrasound: 1 MHz, 1.5-2 W, 5 minutes, continuous (1-2 minute per 1 cm2) It will cover the antero-medial and antro-lateral aspects of the knee around the patella 4.Quadriceps setting 5.VMO setting 6.Education
Category
Rehabilitation
2
Description
b.Intervention Group 1: Supplementary Cycle ergometer program: 1. One minutes pedaling: workload=0, self-selected speed of pedaling (RPM) [Warm-Up period] 2. Five minutes pedaling: RPM=50-60, gradual increase in workload to reach threshold heart rate at the end of 5 minute 3. Ten minutes pedaling: RPM=50-60, controlling the workload to preserve participant’s heart rate at threshold heart rate 4.One minute pedaling: workload=0 and self-selected RPM [Active Recovery] 5.Five minutes rest at sitting position [Passive Recovery]
Category
Rehabilitation
3
Description
c.Intervention Group 2: Supplementary Treadmill program: Test group will take part in a 17-minute exercise program on treadmill as presented below: 1.One minutes walking with self-selected velocity [Warm-Up period] 2.Five minutes walking: gradual increase in velocity to reach threshold heart rate at the end of 5 minute. 3.Ten minutes walking with controlling velocity to preserve participant’s heart rate at threshold heart rate 4.One minute walking: self-selected velocity [Active Recovery] 5.Five minutes rest at sitting position [Passive Recovery]
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Muscoloskeletal Research Center
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Street address
Hezar Jarib Aven. Isfahan University of Medical sciences, Faculty of Rehabilitation Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Vice Chancellor of Research and Technology
Full name of responsible person
Zahra Fallah
Street address
Hejar Jrib Ave. Isfahan University of Medical Sciences, Clinical Council
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Vice Chancellor of Research and Technology
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
Muscoloskeletal Research Center, Department of Physical therapy, Faculty of Rehabilitation Sciences,
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hezar JaribAve. Isfahan University of Medical Sicences, Faculty of Rehabilitation Sciences, Muscoloskeletal Research Center, Department of Physical Therapy
Muscoloskeletal Research Center, Department of Physical therapy, Faculty of Rehabilitation Sciences,
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hezar JaribAve. Isfahan University of Medical Sicences, Faculty of Rehabilitation Sciences, Muscoloskeletal Research Center, Department of Physical Therapy
Muscoloskeletal Research Center, Department of Physical therapy, Faculty of Rehabilitation Sciences,
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hezar JaribAve. Isfahan University of Medical Sicences, Faculty of Rehabilitation Sciences, Muscoloskeletal Research Center, Department of Physical Therapy