The effects of low-load resistance training associated with blood-flow restriction on function, strength and thickness of the quadriceps muscles in COVID-19 survivors after recovery
Effects of low-load resistance training with blood-flow restriction on function, strength and thickness of the quadriceps muscles in COVID-19 survivors after recovery
Design
Randomized clinical trial with control group and double blinded with design of 18 patients. Sealed envelop will be used for randomization.
Settings and conduct
The COVID-19 survivors who are eligible for this study (negative PCR test) based on the inclusion criteria will allocated to experimental or control groups by using simple randomization method. The level of creatine kinase and C reactive protein will check by using blood sampling.The quadriceps muscle thickness will capture by an experienced physiotherapist in rest state as well as during maximum isometric contraction. The muscle strength will assess by using dynamometer.After primary assessments, 12 sessions of low-load training (3 sessions per week) will apply to the patients. for the experimental group. the exercises will apply by blood flow restriction device. after 12 sessions of training, the patient will assess again.
Participants/Inclusion and exclusion criteria
Males and females with the age range of 30-65 years old with grade 3 manual muscle test and body mass index below 30. Exclusion criteria are all factors that blood flow restriction training is contraindicated for them.
Intervention groups
Low-load resistance training associated with blood-flow restriction (BFR) apply in experimental group. In control group we use just low load resistance training without Blood flow restriction.
Main outcome variables
Quadriceps strength; quadriceps muscle thickness; pain pressure threshold by visual analogue scale; sit to stand functional test
General information
Reason for update
Acronym
BFR
IRCT registration information
IRCT registration number:IRCT20210111050007N1
Registration date:2021-05-18, 1400/02/28
Registration timing:registered_while_recruiting
Last update:2021-05-18, 1400/02/28
Update count:0
Registration date
2021-05-18, 1400/02/28
Registrant information
Name
Zinat Ashnagar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8884 2618
Email address
z-ashnagar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of low-load resistance training associated with blood-flow restriction on function, strength and thickness of the quadriceps muscles in COVID-19 survivors after recovery
Public title
The effects of resistance training associated with blood-flow restriction on the quadriceps muscles in CORONA virus survivors after recovery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Males and females with the age range of 30-65 years old which affected by CORONA VIRUS at least from the past 3 months who developed muscles weakness after infection.
The manual muscle testing which graded by MMT should be grade 3 at most.
BMI should be under 30.
Exclusion criteria:
All contraindications of Blood Flow Restriction training should be controlled. Individuals should not have any history of blood clotting, hypertension above 180/100, acute sepsis, blood vessels disorders and varicose veins, cancer, stroke Thrombotic or Hemorrhagic, history of deep vein thrombosis , Arterial fibrillation.
No history of hypertension or diabetes mellitus
No history of fracture, surgery, and knee osteoarthritis
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization by using sealed envelop will be used to allocate the included participants in experimental and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is blind to the allocated group and type of treatment. The main researcher is not blind and apply the experiment ( exercises) on patients.
The assessor is blind to the type of treatment of the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehan University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods street, Keshavarz blvd.,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1148956111
Approval date
2021-02-23, 1399/12/05
Ethics committee reference number
IR.TUMS.FNM.REC.1399.224
Health conditions studied
1
Description of health condition studied
Muscle weakness
ICD-10 code
COVID-19,v
ICD-10 code description
U071
Primary outcomes
1
Description
Muscle thickness
Timepoint
Before and after the intervention
Method of measurement
Ultrasound Imaging
Secondary outcomes
1
Description
C reactive protein level of blood sample
Timepoint
Before and after the intervention
Method of measurement
Blood sample
Intervention groups
1
Description
Intervention group : Using low load exercises with blood flow restriction device using strength training protocol in such a way that 80% of the pressure that causes the pulse to be cut is used . The sports version is in 4 sets with 30 repetitions in the first set and 15 times in the other three sets. Exercises with low load (15-40% of the maximum weight that a person can lift once). The device used is the standard model of the blood flow restriction device, which has vascular Doppler, which has the Smart Tools brand from the United States.
Category
Rehabilitation
2
Description
Control group: Exercises with low load using the cuff of the same device with minimal pressure to prevent the effects of placebo. The number of repetitions and sets as well as the amount of exercise load is similar to the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation faculty,Tehran University of Medical Sciences
Full name of responsible person
Zahra Poursaleh
Street address
Rehabilitation faculty,Tehran University of Medical Sciences, Enghelab street, Pich-e-Shemiran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 3939
Email
z-ashnagar@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ahmad-Reza Khatoonabadi
Street address
Rehabilitation faculty,Tehran University of Medical Sciences, Enghelab street, Pich-e-Shemiran, Tehran, Iran