To determine the effects of progressive resistance exercise training on inflammatory markers, cardiorespiratory fitness, pulmonary function in patients with RA.
Design
Two parallel group , single blinded, randomized control
trial with pre and post assessment
Settings and conduct
Will be conducted in private hospital Ittefaq hospital Lahore
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Patient with RA
• Patients with sedentary lifestyle (no participation in structural exercise for the
preceding 6 months)
• RA factor positive
• Both males and females
• Age between 40-65 years
• Stable disease
• No change in DMARDS (Methotrexate, sulfasalazine, hydroxychloroquine)
Exclusion criteria.
• Joint surgery (in the preceding 6 months)
• Cognitive disability
• Other joint diseases such as Osteoporosis and Osteoarthritis • Previous history of fracture
• Primary neurological disease
• Comorbidity incompatible with exercise
Intervention groups
⚫ Patients will ask to perform four
exercises utilising large muscle groups (eg, leg press, shoulder press, chest press and pull ups). Intensity will determine during their first resistance exercise session using an established protocol.20 They will required to complete three sets of 12–15 repetitions during each exercise session. Mode and intensity of exercise will adjust monthly.
Main outcome variables
6 minutes walk test
Spirometry
Blood test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191117045462N18
Registration date:2024-07-23, 1403/05/02
Registration timing:prospective
Last update:2024-07-23, 1403/05/02
Update count:0
Registration date
2024-07-23, 1403/05/02
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
2024-08-15, 1403/05/25
Expected recruitment end date
2024-12-15, 1403/09/25
Actual recruitment start date
2024-08-15, 1403/05/25
Actual recruitment end date
2024-08-15, 1403/05/25
Trial completion date
2024-12-25, 1403/10/05
Scientific title
Effects of resistance training on inflammatory markers, cardiorespiratory fitness and pulmonary functions in patients with Rheumatoid arthritis.
Public title
Effects of resistance training on inflammatory markers, cardiorespiratory fitness and pulmonary functions in patients with Rheumatoid arthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Patient with RA
Patients with sedentary lifestyle (no participation in structural exercise for thepreceding 6 months)
RA factor positive
Both males and females
• Age between 40-65 years
• Stable disease
Exclusion criteria:
Joint surgery (in the preceding 6 months)
Cognitive disability
Other joint diseases such as Osteoporosis and Osteoarthritis
Previous history of fracture
• Primary neurological disease
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group through Random Sampling sealed opaque enveloped.
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigator will be blind. Assesmnt will be done by 2nd therapist who will not be involved in treatment and data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah College of rehabilitation & Allied health sciences
Street address
25 Raza Saeed Rd, Bhabra block M Gulberg III, Lahore. Punjab
City
Lahore
Postal code
54000
Approval date
2024-01-15, 1402/10/25
Ethics committee reference number
RCR&ACHS/REC/MS-CPPT
Health conditions studied
1
Description of health condition studied
Patients with rheumatoid arthritis
ICD-10 code
M06
ICD-10 code description
Other rheumatoid arthritis
Primary outcomes
1
Description
Resistance training
Timepoint
Pre post treatment
Method of measurement
6 minutes walk test,spirometry, blood test
Secondary outcomes
1
Description
Inflammatory markers
Timepoint
Pre post treatment
Method of measurement
Blood Test ( Complete Blood Count)
Intervention groups
1
Description
Intervention group: Resistance exercise training: Patients will ask to perform four exercises utilizing large muscle groups (eg, leg press, shoulder press, chest press and pull ups). Intensity will determine during their first resistance exercise session using an established protocol. They will required to complete three sets of 12–15 repetitions during each exercise session. Each exercise session will be last about 20 to 30 minutes, depending on the individual's tolerance and fitness level. Frequency will be aimed for 2-3 sessions per week. This frequency allows for adequate recovery between sessions while providing enough stimulus to improve fitness over time. Mode and intensity of exercise will adjust monthly.
Category
Rehabilitation
2
Description
Control group: conventional therapy along with verbal advice about the cardiovascular and arthritis related benefits of exercise for the same period
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Riphah college of rehabilitation & Allied Health Sciences
Street address
25 Raza saeed Rd, Bhabra block M Gulberg III, Lahore. Punjab
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Dr wajiha
Street address
25 Raza saeed Rd, Bhabra Block M Gulberg III, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Grant name
Educational
Grant code / Reference number
No
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah international university
Proportion provided by this source
100
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
Aqsa Riaz
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
95A Lda avenue 1, Raiwind road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 42 35126110
Email
aqsariaz246@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Wajeeha zia
Position
Senior lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
25 Raza saeed Rd, Bhabra Block M Gulberg III, Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Aqsa Riaz
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
95A, lda avenue 1 raiwind road, Lahore.
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 336 3073766
Email
aqsariaz246@gmail.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
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