The effect of low-intensity exercise bicycles with and without restriction of blood flow to strengthening the quadriceps muscles in patients with post-polio syndrome: randomized controlled trial
The aim of this study is to determine the effect of low-intensity exercise bikes with and without restriction of blood flow on strengthening of the quadriceps muscle in the post-polio syndrome.
Inclusion criteria: Men with the known syndrome as post-polio with records in the disabled community in Tabriz, age between 20 to 60 years, the ability to walk at least at home with or without assistive devices, the ability to pedal a stationary bicycle loaded with at least 25 watts. Exclusion criteria: having other co-morbidities, the use of steroids and sports supplementation during 3 months ago, and a regular physical activity program.
Method: This study is a randomized controlled clinical trial. 60 eligible men will be selected and randomly allocated into three groups. The first intervention group will receive the stationary bicycle exercise without limitation of blood flow, the second intervention group will receive stationary bicycle exercise with limited blood flow, and control will not receive any intervention. This intervention will be lasted for 8 weeks in three groups of 20 persons.
Primary outcome: Improvement some of the features of the quadriceps muscle (hypertrophy, strength, anthropometric indices and the electrical activity of muscles).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050827359N4
Registration date:2017-06-20, 1396/03/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-20, 1396/03/30
Registrant information
Name
Seyed Kazem Shakouri
Name of organization / entity
Tabriz University of Medical Sciences, Physical mediacine and rehabilitation department
Country
Iran (Islamic Republic of)
Phone
+98 33364672
Email address
shakorik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical Medicine and Rehabilitation Research Center
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-20, 1396/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low-intensity exercise bicycles with and without restriction of blood flow to strengthening the quadriceps muscles in patients with post-polio syndrome: randomized controlled trial
Public title
The effect of bike exercise with restriction of blood flow to strengthening the quadriceps muscles in patients with post-polio syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
Men with the known syndrome as post-polio with records in the disabled community in Tabriz; Ages between 20 to 60 years; The ability to walk at least at home, with or without assistive devices; The ability to pedal a stationary bicycle loaded with at least 25 watts; Life expectancy at least more than a year
Exclusion criteria The use of psychotropic drugs or other forms of psychotherapy; Depressive men according to the Beck depression (more than 6); Having other comorbidities, according to medical examination and information in the medical records that limit interventional programs such as cardiovascular diseases, uncontrolled hypertension, seizures, uncontrolled diabetes, etc.; Failure to complete a questionnaire and carry out the necessary preliminary examination; The use of steroids and sports supplementation during 3 months ago; Having a regular physical activity program
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ehics Committee
Street address
Department of Research and Technology, third floor, Central Building, No. 2, Tabriz University of Medical Sciences, Golgasht, Tabriz, Iran.
City
Tabriz
Postal code
Approval date
2017-04-24, 1396/02/04
Ethics committee reference number
IR.TBZMED.REC.1396.81
Health conditions studied
1
Description of health condition studied
postpolio syndrome
ICD-10 code
G14
ICD-10 code description
Postpolio syndrome
Primary outcomes
1
Description
Muscle hypertrophy
Timepoint
First and last day of intervention
Method of measurement
Using anthropometry
2
Description
Muscle strength
Timepoint
First and last day of intervention
Method of measurement
Using isokinetic
3
Description
Range of joint motion
Timepoint
First and last day of intervention
Method of measurement
With a goniometer
4
Description
The electrical activity of muscles
Timepoint
First and last day of intervention
Method of measurement
Using EMG
Secondary outcomes
1
Description
The mean of Quality of life
Timepoint
Baseline, end of 4th week, end of 8th week
Method of measurement
Using WHO quality of life questionnaire
2
Description
GH
Timepoint
First and last day of
Method of measurement
Bloodletting
3
Description
IGF1
Timepoint
First and last day of
Method of measurement
Bloodletting
4
Description
Testosterone
Timepoint
First and last day of
Method of measurement
Bloodletting
Intervention groups
1
Description
The control group will receive no intervention and positive results, after the completion of research, will also be provided to the control group.
Category
N/A
2
Description
The first intervention group will receive resistance training without restricted blood flow. Exercises will be started with a speed of 2 km/h for 3 minutes on a stationary bike with low resistance to warm up the body and then be continued at a speed of 3 km/h for 15 minutes. The participants will be given a 60-second rest between each 5-minute exercise. After 15 minutes, pedal is pressed 2 minutes at a speed of 1 km/h to reduce the amount of muscle fatigue caused by physical activity. The intervention period will be lasted for eight weeks: three days a week on even days, 1 hour a day (from 18 to 19 ) in a group of 20 people that will be implemented by the attending physician.
Category
Rehabilitation
3
Description
The second intervention group will receive resistance training with restricted blood flow. Exercises will be started with a speed of 2 km/h for 3 minutes on a stationary bike with low resistance to warm up the body and then a five-centimeters tourniquet cuff is closed around the proximal of thighs for setting an obstructive pressure of 90 mm Hg pressure by barometer. Exercises will be continued at a speed of 3 km/h for 15 minutes and participants will be given a 60-second rest between each 5-minute exercise. After 15 minutes, pedal is pressed 2 minutes at a speed of 1 km/h without tourniquet cuff to reduce the amount of muscle fatigue caused by physical activity. The intervention period will be lasted for eight weeks: three days a week on odd days, 1 hour a day (from 18 to 19 ) in a group of 20 people that will be implemented by the attending physician.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz disabled community
Full name of responsible person
Saeid Biczadeh
Street address
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research, Tabriz University of Medical Science
Full name of responsible person
Dr. Mohammadreza Rashidi
Street address
3rd floor, Central building number 2, Tabriz University of Medical Science , Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Tabriz University of Medical Science
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
Physical Medicine and Rehabilitation group, Tabriz University of Medical Science
Full name of responsible person
Dr. seyed Kazem Shakouri
Position
Specialist in physical medicine and rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation ward, Imamreza hospital, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 3336 1928
Fax
Email
skshakouri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physical Medicine and Rehabilitation group, Tabriz University of Medical Science
Full name of responsible person
Dr. Seyed Kazem Shakouri
Position
Specialist in Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation ward, Imamreza hospital, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 3336 1928
Fax
Email
skshakouri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Physical Medicine and Rehabilitation group, Tabriz University of Medical Science
Full name of responsible person
Dr. Seyed Kazem Shakouri
Position
Specialist in Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation ward, Imamreza hospital, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 3336 1928
Fax
Email
skshakouri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)