Evaluation of the efficacy of aerobic exercise and strength training in patients with rheumatoid arthritis
Design
This study was designed as a single-blind randomized clinical trial. 81 patients with confirmed rheumatologist diagnosis for 8 weeks were randomly divided into three groups of aerobic exercise, strength exercise and control group. The severity and quality of rheumatoid arthritis were assessed according to DAS28 criteria and severity and quality of life of these patients were assessed using WHOQOL-BREF brief questionnaire before and after intervention. Data were collected at the beginning and end of the course.
Settings and conduct
The study was performed at Imam Khomeini Hospital of Sari University of Medical Sciences. The study was a single blind randomized clinical trial. Participants were unaware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with a history of up to 10 years; age between 30 and 60 years old; absence of deformity; severity of disease according to DAS28 criteria less than 3.2; daily corticosteroid consumption less than 15 mg; no cardiovascular risk factors high; no fractures or soft tissue injury or mental disorders.
Exclusion criteria: lack of satisfaction with the plan; inability to perform a 6 minute walk test or one-repetition maximum test.
Intervention groups
This study included two intervention groups and one control group in patients with rheumatoid arthritis. Two groups of exercise therapy included aerobic walking and strength training. Both groups also received drug treatment intervention. In the control group only drug treatment is given.
Main outcome variables
This study investigated the effect of two types of exercise therapy on the quality and severity of disease and quality of life in patients with rheumatoid arthritis compared with the control group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200131046322N1
Registration date:2020-03-09, 1398/12/19
Registration timing:retrospective
Last update:2020-03-09, 1398/12/19
Update count:0
Registration date
2020-03-09, 1398/12/19
Registrant information
Name
Zahra Madani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3360 8570
Email address
z.madani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2020-01-22, 1398/11/02
Scientific title
The effect of 8 weeks of home exercise training on quality of life and quality of disease in patients with rheumatoid arthritis
Public title
The effect of exercise on rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient was diagnosed with rheumatoid arthritis based on the diagnostic criteria and get rheumatologist approval.
Patient age between 30 and 60 years
The duration of illness is less than 10 years from diagnosis.
The patient has no deformity.
Do not be in active phase of inflammation while performing patient plan.
The severity of the disease was less than 3.2 based on criteria DAS28, It means the severity of the disease is mild or in remission.
The patient should take a lower dose of 15 mg corticosteroid.
The patient is not a high risk cardiovascular risk factor.(Severe diabetes, severe hypertension, severe cardiovascular disease)
Do not experience trauma or fracture or soft tissue damage during design.
Do not suffer from problems such as psychosis or severe depression for psychological issues.
Exclusion criteria:
The patient is not satisfied with the plan or has no reason to continue cooperating while performing the plan.
Unable to cooperate in field exercise test (6 minutes walk) and One-repetition maximum test.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
81
Actual sample size reached:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into three study arms using a closed envelope A for control, B for intervention group (1) and C for intervention group (2).
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were unaware of the allocation of study groups That is, they did not know that there were two groups of exercise therapists in clinical trials but were aware of their group's exercise therapy.
Placebo
Not used
Assignment
Parallel
Other design features
Patients who were included in the study were randomly divided into three groups of aerobic exercise and strength exercise and control group. Intervention groups received exercise therapy in addition to drug therapy for 8 weeks but control group only received medication for 8 weeks.At the begining and the end of study assessment tools for three groups were evaluated.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational Ethics Committee of Imam Hospital of Mazandaran University of Medical Sciences
Street address
Amir Mazandarani Ave, Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
3313148166
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.060
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05.9
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor, unspecified
Primary outcomes
1
Description
Severity score of rheumatoid arthritis using Disease Activity Score (DAS)28 questionnaire
Timepoint
Before and after intervention
Method of measurement
Disease Activity Score (DAS)28 questionnaire
2
Description
Determining the quality of life of patients using WHOQOL-BREF short questionnaire
Timepoint
Before and after intervention
Method of measurement
WHOQOL-BREF short questionnaire
Secondary outcomes
1
Description
Chest press One-repetition maximum test
Timepoint
Before and after the intervention of strength exercise
Method of measurement
Machine chest press
2
Description
Leg press one-repetition maximum test
Timepoint
Before and after the intervention of strength exercise
Method of measurement
Machine leg press
Intervention groups
1
Description
Intervention group: Aerobic exercise (walking) and medication .Aerobic exercise training was recommended for 2 weeks, three to five days a week, 30 to 60 minutes daily, with an intensity of 60 to 80 percent of maximum heart rate.
Category
Treatment - Other
2
Description
Intervention group: Strength Exercise Therapy (Weight) and medication .Strength training was taught to patients by dumbbells for 8 week, 2 to 3 days a week, 2 to 3 sets with 8 to 12 repetitions with an intensity 60 to 80% of One-repetition maximum.
Category
Treatment - Other
3
Description
Control group: Medication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatologic Clinic and Sport Medicine Center of Imam Khomeini Hospital
Full name of responsible person
Zahra Madani
Street address
Sport Medicine Center , Mostafavian Clinic , 3th Ave, Razi St
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
z.madani@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saidi
Street address
Central Headquarters of Mazandaran University of Medical Science , Valiasr Highway , Jouybar Three ways ,Sari
City
Sari
Province
Mazandaran
Postal code
3397148157
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
Majidsaidi@gmail.com
Grant name
1290004
Grant code / Reference number
1602001000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Madani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 6 , Mostafavian Clinic , 3th Ave , Razi St
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
z.madani@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Dayer
Position
Assistant of Sport Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No 6 , Mostafavian Clinic , 3th Ave , Razi St
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
afshin.dayer@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Dayer
Position
Assistant of Sport Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No 6 , Mostafavian Clinic , 3th Ave , Razi St
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
afshin.dayer@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient data will be published as non-identifiable files for one year after the publication of the article for clinical and academic researchers.
When the data will become available and for how long
Applicants will be able to access the data 6 months after the paper printout for one year.
To whom data/document is available
Academic and Clinical Researchers
Under which criteria data/document could be used
Use the document only with the permission of the lead researcher and with the condition of participation in the ongoing research work.
From where data/document is obtainable
1-Zahra Madani to Email Adress: z.madani@mazums.ac.ir
2-Afshin Dayer to Email Adress: afshin.dayer@gmail.com
What processes are involved for a request to access data/document
The request must first be submitted by email.The person must be fully identifiable with the credentials and indicate the exact reason for the request.After the request is confirmed and the applicant have been identified , the data will be made available to the applicant within one week.