The Effect of Functional Electrical Stimulation Intervention on Fatigue, Muscle Strength, Muscle Mass and Quality of Life in Older Adults with COVID-19
The effect of functional electrical stimulation intervention on fatigue, muscle strength, muscle mass and quality of life in older adults with COVID-19
Design
A randomized clinical trial study with parallel groups, Double-blinded on 40 patients, Randomization will be done simply by random numbers table.
Settings and conduct
This study is performed with the voluntary participations with COVID-19 at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences. The intervention group will receive functional electrical stimulation but the other group will receive sham functional electrical stimulation. In both groups, treatment sessions include 10 consecutive treatment sessions. To evaluate the effects of functional electrical stimulation, participants in both groups were evaluated before and after the intervention. Patients and evaluator are blind.
Participants/Inclusion and exclusion criteria
Elderly people with COVID-19 after hospital discharge; Age over 60 years؛ Obvious atrophy of the Quadriceps and Tibialis anterior muscles; Normal level of alertness ,orientation and responsiveness to verbal stimulus; To be willing to participate in the study
Intervention groups
The first group will receive functional electrical stimulation during 10 sessions of rehabilitation treatment. The second intervention group will receive sham functional electrical stimulation during 10 sessions of rehabilitation treatment.
Main outcome variables
fatigue; muscle strength; muscle mass; quality of life
General information
Reason for update
Acronym
COVID-19
IRCT registration information
IRCT registration number:IRCT20201102049234N2
Registration date:2021-10-26, 1400/08/04
Registration timing:registered_while_recruiting
Last update:2021-10-26, 1400/08/04
Update count:0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
Mona Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3332 8502
Email address
mona.ramezani.sa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Functional Electrical Stimulation Intervention on Fatigue, Muscle Strength, Muscle Mass and Quality of Life in Older Adults with COVID-19
Public title
The Effect of Functional Electrical Stimulation Intervention in Treatment of Older Adults with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly People with COVID-19 After Hospital Discharge
Age Over 60 Years
Obvious Atrophy of the Quadriceps and Tibialis Anterior Muscles
Normal Level of Alertness ,Orientation and Responsiveness to Verbal Stimulus
To Be Willing to Participate in the Study
Exclusion criteria:
Pregnancy
Known or Suspected Malignancy in the Lower Limb
Body Mass Index Equal or Greater than 35 Kilogram Per Square Meter
Conditions Preventing Electrical Stimulation Treatment for Example Deep Vein Thrombosis and Rhabdomyolysis
Skin Lesions at the Site of Electrical Stimulation
Diagnosis of Alzheimer's Disease, Degenerative Disease and Polyneuropathy
Conditions Preventing Outcome Assessment for Example Amputation or Inability to Walk
Presence of an Implanted Cardiac Pacemaker or Defibrillator
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with a random number table such that each person is given a code and they are written in a table. We select one place from the table in a blinded manner. Then we select 12 numbers smaller than the selected number in the same row. The same would be true for the treatment and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher will be blind to the intervention using the research assistant and he/she is absent in the treatment room. The outcome evaluator will vary with the researcher and research data be given him with code and is unaware of the participants intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Headquarters of Semnan University of Medical Sciences, Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-09-28, 1400/07/06
Ethics committee reference number
IR.SEMUMS.REC.1400.153
Health conditions studied
1
Description of health condition studied
Coronavirus disease (COVID-19)
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Fatigue
Timepoint
Before the intervention and after the end of intervention
Method of measurement
Chalder fatigue questionnaire
2
Description
Muscle Strength
Timepoint
Before the intervention and after the end of intervention
Method of measurement
Biofeedback pressure device
3
Description
Muscle Mass
Timepoint
Before the intervention and after the end of intervention
Method of measurement
Ultrasonographic device
4
Description
Quality of Life
Timepoint
Before the intervention and one month after the start of intervention
Method of measurement
WHOQOL-BREF questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group will receive functional electrical stimulation during 10 sessions of rehabilitation treatment. The patient will sit on a chair. FES will apply bilaterally using an electrical stimulator (710 P-plus, Iran) with pairs of electrodes (10 × 5 cm) placed transversally on the quadriceps muscle (5 cm below the inguinal crease and 5 cm above the patella). The stimulation protocol consists in the application of symmetrical biphasic rectangular pulses with a frequency of 30 Hz (pulse duration: 400 μs). The total duration of the FES session is 30 minutes. Thus eliciting a total of 90 evoked contractions per day. Stimulation intensity will adjust daily by the physical therapist to elicit a visible twitch in each muscle. The maximal stimulation intensity will record for each session and considered as a surrogate marker of FES dose. The patient will sit on a chair. FES will apply bilaterally using an electrical stimulator with pairs of electrodes (10 × 5 cm) placed transversally on the anterior tibialis muscle. One electrode will place over the motor point of the TA muscle and the other will place immediately below the belly of the muscle. FES will be apply for 20 minutes (pulse duration μs) with a frequency of 50 Hz.
Category
Treatment - Devices
2
Description
Control group: The second intervention group will receive sham functional electrical stimulation during 10 sessions of rehabilitation treatment. Sham FES will follow the same procedures, but the device will switch on only for the initial 20 seconds, with the current then diminish to zero. The patients will inform of the possibility of feeling a slight initial tingling that would either diminish, disappear or continue during the 20-minute session.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan unuversity of medical science, Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fariba Ramezani
Street address
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519618375
Phone
+98 23 8502 3332
Email
mona.ramezani.sa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Kookhaee
Street address
Headquarters of Semnan University of Medical Sciences, Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
35147999442
Phone
+98 23 8998 3344
Fax
+98 23 8999 3344
Email
info@semums.ac.ir
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
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
Semnan University of Medical Sciences
Full name of responsible person
Fariba Ramezani
Position
Master Student of Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519618375
Phone
+98 23 8502 3332
Email
mona.ramezani.sa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519618375
Phone
+98 23 8502 3332
Email
fatemehehsani59@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fariba Ramezani
Position
Master Student of Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519618375
Phone
+98 23 3332 8502
Email
mona.ramezani.sa@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available