Comparison of the effect of walking and Pilates exercise at home on quality of life, functional capacity and anthropometric measurements in elderly women with diabetes type 2
Comparing the effect of walking and Pilates exercises at home on the quality of life in elderly women with diabetes
Design
This study is a randomized clinical trial. First, 100 qualified patients will be selected using convenience sampling. Then Participants will be allocated into two groups using Randomizer software.
Settings and conduct
This randomized clinical trial will be done on 100 diabetic patients. Due to the nature of the interventions, only the outcome assessor will be blinded.
First, qualified patients will be selected using convenience sampling. Then Participants will be allocated into two groups by simple randomization method.
Data was gathered in three times; before intervention, immediately and one months after intervention.
Depending on the type of intervention, participants will go to the gym to participate in training sessions. After participating in 2 session training under supervision of sports expert, if they will be competent for doing exercise at home independently, they will done intervention at home 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria;
At least one year of history of type 2 diabetes
Age 60-75 years
lack of disability
lack of psychiatric disorders
Exclusion criteria;
Under diet to lose weight
Being hospitalized
Living in a nursing home
Contraindication of physical exercises based on physician advice
Intervention groups
Intervention 1 (Walking): After holding two training sessions under supervision of a sports expert, participants will be asked to walk at home 45 minutes, 3 times a week for 12 weeks.
Intervention 2 (Pilates exercises): After holding two training sessions under supervision of a sports expert, participants will be asked to do prescribed Pilates exercises at home 45 minutes, 3 times a week for 12 weeks.
Main outcome variables
Quality of life; Functional capacity; َAnthropometric indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140412017237N12
Registration date:2020-11-20, 1399/08/30
Registration timing:prospective
Last update:2020-11-20, 1399/08/30
Update count:0
Registration date
2020-11-20, 1399/08/30
Registrant information
Name
Mahnaz Modanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
modanloo.mahnaz@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of walking and Pilates exercise at home on quality of life, functional capacity and anthropometric measurements in elderly women with diabetes type 2
Public title
The effect of walking and Pilates exercise at home on quality of life, functional capacity and anthropometric measurements in elderly women with diabetes type 2
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
History of Diabetes mellitus type 2 from 1 year ago
60-75 years old
Lack of physical disability
Lack of known psychiatric disorder
Lack of diabetes complications
Exclusion criteria:
Under weight lost diet
Contraindication of physical exercises based on physician advice
Nursing home residents
Hospitalization
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible patients as an unit of randomization will be allocated in two intervention groups (1:walking at home, 2: Pilates exercise at home) using Randomizer software by simple randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the interventions, only the outcome assessor will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-09-27, 1399/07/06
Ethics committee reference number
ir.goums.rec.1399.208
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Quality of life
Timepoint
Quality of life measurement before intervention and immediately and one months after intervention
Method of measurement
Quality of life questionnaire (SF-36)
Secondary outcomes
1
Description
Functional capacity
Timepoint
Measurement of functional capacity before intervention and immediately and one months after intervention
Method of measurement
Evaluated by TUG, 2-10MWT, STS5-3, OLS tests.
2
Description
Anthropometry
Timepoint
Measurement of anthropometric indicators before intervention and immediately and one months after intervention
Method of measurement
Measuring body dimensions in a static state, which includes height, weight, body mass index, waist circumference, pelvic circumference, waist-to-height ratio, waist-to-hip ratio, mass and body fat percentage of patients. Weight will be measured using a digital scale made in Iran with an accuracy of 100 grams, height, waist circumference, pelvic circumference using a tape measure made in Iran with an accuracy of 0.1 cm. Body fat percentage will be measured using the BIA by the OMRON BF-511.
Intervention groups
1
Description
Intervention group 1 (walking at home): Walking at home for 45 minutes, three times a week for 3 months, which will be performed by an experienced instructor after training.
Category
Other
2
Description
Intervention group 2 (Pilates exercises at home): A selection of Pilates exercises at the beginner and basic level of Pilates is done lying down and without special tools at home. These movements are accompanied by the coordination of inhaling and exhaling in the performance of the movement, which will be for 45 minutes, three times a week for 3 months, which will be performed by an experienced instructor after training.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
5th Azar Medical and Educational Center
Full name of responsible person
Nasser Saffar
Street address
6th Azar, 5Azar Street, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Fax
+98 17 3222 8363
Email
modir-5azar@goums.ac.ir
Web page address
http://goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
honarvar@goums.ac.ir
Web page address
http://goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Mahnaz Modanloo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Nursing Research Center, Golestan University of Medical Sciences, Hirkan Boulevard
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
modanloo.mahnaz@goums.ac.ir
Web page address
http://goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hamideh Akbari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Endocrinologist
Street address
Department of Internal medicine, Faculty of Medicine, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3222 0561
Fax
+98 17 3245 2225
Email
dr.akbari.h@gmail.com
Web page address
http://goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Maleki
Position
Ms Student of Geriatrics Nursing
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
0981732456900
Fax
+98 17 3245 5171
Email
malekifatemeh51@yahoo.com
Web page address
http://goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
All data will be shared after unidentifiable participants.
When the data will become available and for how long
6 months after publication the data files will be available.
To whom data/document is available
The data will be shared for people working in academic institutions.
Under which criteria data/document could be used
Meta analyses on data is permitted.
From where data/document is obtainable
Please contact to person responsible for general inquiries.
What processes are involved for a request to access data/document
The data will be available through email.
Comments
Please contact to both email address:
modanloo.mahnaz@goums.ac.ir
modanloo.mahnaz@gmail.com