Effects of comprehensive muscle endurance training with and without Fitness training program on muscle strength, endurance and Quality of life in post COVID-19 patients
To study the effects of fitness training program and comprehensive muscle endurance
training along with fitness training program on muscle strength, endurance and quality
of life in post COVID-19 patients
Design
Patients will be recruited in the study through a convenient sampling technique and then will be randomly assigned
to each group according to consort guideline 2010. Participants are 40 persons. Written informed consent will be taken. After enrollment into the study, patients will be allocated either to group A or Group B by lottery method. No. of Chits will be equal to the total sample size, odd Numbers will be allocated to Group A and even numbers will be allocated to Group B. No blinding.
Settings and conduct
The study will be conducted at Fatima Memorial Hospital, LHR.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged18 to 40 years; both genders; Post Covid-19 patients; Hemodynamically stable; Non-diabetic patients; Non- Hospitalized Patients. Exclusion criteria: Neuromuscular disease; Unstable cardiovascular disease; Musculoskeletal disease; Pregnancy; Rib Fracture; Risk of Pneumothorax; Pneumonectomy; Red Flags Like: Fever, Night Sweats, Malaise; Pulmonary embolism; Lung cancer.
Intervention groups
Group B: will be treated with supervised combined strength-endurance training (CT).
Exercises consisted of 30 minutes of cycling, treadmill walking, or using an upper limb ergometer.
Group A: will be treated according to physical activity education program approach
(EDU), based on a periodically supervised protocol of different exercise. The EDU
program was scheduled as follows: Each supervised training session lasted 60 min
and included 3 alternating types of physical activity: aerobics classes with flexibility
and balance training.
Main outcome variables
Strength, endurance, and quality of life in post covid patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191117045462N7
Registration date:2022-04-28, 1401/02/08
Registration timing:registered_while_recruiting
Last update:2022-04-28, 1401/02/08
Update count:0
Registration date
2022-04-28, 1401/02/08
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-01, 1401/01/12
Expected recruitment end date
2022-07-01, 1401/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of comprehensive muscle endurance training with and without Fitness training program on muscle strength, endurance and Quality of life in post COVID-19 patients
Public title
Effects of comprehensive muscle endurance training with and without Fitness training program on muscle strength, endurance and Quality of life in post COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged18 to 40 years
Both genders
Post Covid-19 patients
Hemodynamically stable
Non-diabetic patients
Non- Hospitalized Patients
Exclusion criteria:
Neuromuscular disease
Unstable cardiovascular disease
Musculoskeletal disease
Pregnancy
Rib Fracture
Risk of Pneumothorax
Pneumonectomy
Red Flags Like: Fever, Night Sweats, Malaise
Pulmonary embolism
Lung cancer
Age
From 18 years old to 40 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After enrollment into the study, patients will be allocated either to group A or Group B by lottery method. No. of Chits will be equal to total sample size, odd Numbers will be allocated to Group A and even numbers will be allocated to Group B.
Each patients will be requested to draw a chit from the box and after that patient will be recruited into either group A or group B.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of the Riphah international university Lahore, Pakistan
Street address
Shadman
City
Lahore
Postal code
54000
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
567888
Health conditions studied
1
Description of health condition studied
Post COVID
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Flexibility
Timepoint
4 weeks
Method of measurement
Sit and reach test, one leg stance test
2
Description
strength
Timepoint
4 weeks
Method of measurement
Chest press and leg extension assessed separately for upper body and bilateral lower limb strength.
Secondary outcomes
1
Description
Quality of life
Timepoint
4 weeks
Method of measurement
Health related quality of life (HRQoL) for quality of life
Intervention groups
1
Description
Intervention group: Group A will be treated according to physical activity education program approach (EDU), based on a periodically supervised protocol of different exercise. The EDU program was scheduled as follows: Each supervised training session lasted 60 min and included 3 alternating types of physical activity: aerobics classes with flexibility and balance exercises, walking, or weight-free exercises in circuit training for 6 weeks. First week supervised and then patient will perform for 3 days/week for 6 weeks
Category
Treatment - Other
2
Description
intervention group: Group B will be treated supervised combined strength-endurance training (CT). Exercises consisted of 30 minutes of cycling, treadmill walking or using an upper limb ergometer at intensity from 3 to 4 out of 0–10 on the CR-10 modified Borg scale for 3 days/week for 6 week
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Memorial Hospital, Lahore.
Full name of responsible person
Maryum Khan
Street address
Shadman
City
Lahore
Postal code
54000
Phone
+92 308 4058718
Email
marykhan2.mk@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Street address
Shadman
City
Lahore
Postal code
54000
Phone
+92 308 4058718
Email
wajeeha_z@yahoo.com
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International University
Proportion provided by this source
10
Public or private sector
Private
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
Riphah International University
Full name of responsible person
Wajeeha
Position
physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
physiotherapy
Street address
Shadman
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 308 4058718
Email
wajeeha_z@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation and research
Street address
Shadman
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 37427465
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
wajeeha Zia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation and research
Street address
Shadman
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 37427465
Email
wajeeha_z@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not 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