Effect of water-based resistance training with blood flow restriction on functional capacity,heart rate variability, electrical activity of quadriceps muscles and knee joint kinematic while walking in postmenopausal women with knee osteoarthritis.
Determining the effect of resistance training with blood flow restriction in water on functional capacity, heart rate variability, electrical activity of quadriceps muscles and knee joint kinematics during walking in postmenopausal women with knee osteoarthritis
Design
A clinical trial with a control group, with parallel groups (resistance in water, resistance with blood flow restriction), Restricted randomization with a stratified method, on 45 patients with 2nd and 3rd degree arthritis, postmenopausal women, Gpower software was used for the sample size in three groups.
Settings and conduct
Training sessions will be conducted in the culture pool of Qaen city under the supervision of the physiotherapist and the research team. The desired tests will be conducted in the Physiology Laboratory of Birjand University.
Participants/Inclusion and exclusion criteria
Postmenopausal women with grade 2 and 3 arthritis; No history of cardiovascular disease; non-smokers; Not suffering from skin and contagious diseases that can be transmitted by water; not taking non-steroidal and anti-inflammatory drugs in the last 3 months; No injection of corticosteroids in the last 6 months; No surgery or other invasive procedure on the knee in the last 6 months
Intervention groups
The Progressive resistance group in the water by tying weights to the ankles and performing hydrotherapy movements for knee strengthening, The Progressive resistance group with blood flow restriction in the water by tying a cuff around the thigh and tying weights to the ankles and performing hydrotherapy movements for knee strengthening, The Control group did not receive any activities under the supervision of the research group and did their normal life activities
Main outcome variables
Heart rate variability; Knee kinematic condition while walking; Electrical activity of the quadriceps muscle; Functional capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240911063005N1
Registration date:2024-09-22, 1403/07/01
Registration timing:prospective
Last update:2024-09-22, 1403/07/01
Update count:0
Registration date
2024-09-22, 1403/07/01
Registrant information
Name
samaneh baniasadi
Name of organization / entity
University Of Birjand
Country
Iran (Islamic Republic of)
Phone
+98 56 3249 9419
Email address
samaneh_baniasadi@birjand.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of water-based resistance training with blood flow restriction on functional capacity,heart rate variability, electrical activity of quadriceps muscles and knee joint kinematic while walking in postmenopausal women with knee osteoarthritis.
Public title
Comparison of resistance exercises in water with and without blood flow restriction on people with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women with grade 2 and 3 arthritis
No history of cardiovascular disease
Non-smokers
Absence of skin and contagious diseases that can be transmitted by water
Not taking non-steroidal and anti-inflammatory drugs in the last 3 months
No injection of corticosteroids in the last 6 months
No surgery or other invasive procedure on the knee in the last 6 months
Exclusion criteria:
Menopause of people
Arthrosis degree lower than 2 and higher than 3
History of cardiovascular disease
Age
From 45 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Limited randomization and stratified method considering homogeneity in anthropometric characteristics (weight, Age of menopause and body mass index in three groups)
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
Ethics Committee in Birjand University Research
Street address
Birjand University Campus., University Blvd., at the end of Shahid Avini Boulevard
City
Birjand
Province
South Khorasan
Postal code
9717434765
Approval date
2024-02-21, 1402/12/02
Ethics committee reference number
IR.BIRJAND.REC.1402.016
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Functional capacity
Timepoint
Measurement of functional capacity 48 hours before the start and 48 hours after the end of the study
Method of measurement
Chair stand test, walking speed, timed walking test, 2-minute walk and rise test (TUG) and dynamic balance
2
Description
Heart rate variability
Timepoint
Measurement of heart rate variability 48 hours before the start and 48 hours after the end of the study
Method of measurement
Polar heart rate monitor
3
Description
Electrical activity of quadriceps muscles
Timepoint
Measurement of electrical activity of quadriceps muscles 48 hours before the start and 48 hours after the end of the study
Method of measurement
Electromyography device(EMG)
4
Description
Knee joint kinematics while walking
Timepoint
Measurement of knee joint kinematics while walking 48 hours before the start and 48 hours after the end of the study
Method of measurement
Inertial measurement unit device(IMU)
Secondary outcomes
1
Description
Pain
Timepoint
48 hours before the start and after the end of the study
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index Questionnaire
Intervention groups
1
Description
Intervention group: Water resistance for 8 weeks and 3 sessions per week with progressive weights and knee therapy exercises
Category
Treatment - Other
2
Description
Intervention group: resistance along with blood flow restriction in water for 8 weeks and 3 sessions every week for 45 minutes, therapeutic knee exercises in water with a cuff around the thigh and weight on the ankle during the main exercises.
Category
Treatment - Other
3
Description
Control group: They do not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology specialist doctor's office
Full name of responsible person
Dr. Zeinab Sarmi
Street address
Shafa doctors building, Taleghani 20
City
birjand
Province
South Khorasan
Postal code
9761771856
Phone
+98 905 534 5420
Email
z.13612002@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Birjand
Full name of responsible person
Abulfazl Akbarpour
Street address
Birjand University Campus, University Boulevard, at the end of Shahid Avini Boulevard
City
Birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3102 2001
Fax
+98 56 3220 2515
Email
akbarpour@birjand.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Birjand
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Birjand
Full name of responsible person
Mohsen Mohammadnia Ahmadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports physiology
Street address
Birjand University Campus, University Boulevard, at the end of Shahid Avini Boulevard
City
Birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3102 5000
Email
m.m.ahmadi2005@birjand.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Birjand
Full name of responsible person
Mohsen Mohammadnia Ahmadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports physiology
Street address
Birjand University Campus, University Boulevard, at the end of Shahid Avini Boulevard
City
Birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3102 5000
Email
m.m.ahmadi2005@birjand.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Birjand
Full name of responsible person
samaneh baniasadi
Position
PhD student in physical education
Latest degree
Master
Other areas of specialty/work
Sports physiology
Street address
No. 4., between 8 and 10 Abu Talib., Abu Talib Blvd
City
Qaen
Province
South Khorasan
Postal code
9761771856
Phone
+98 56 3249 9419
Email
samaneh_baniasadi@birjand.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available