Protocol summary

Summary
This study is a clinical trial study. The aim of this study was to investigate the effects of Pilates exercises on attitude to diabetes and quality of life in elderly women with type 2 diabetes. The data gathering tool was a CASP19 questionnaire, a DAS-3 questionnaire, a demographic questionnaire, and a short-term ATMS test. Patients with a randomized allocation process are divided into two groups of control and intervention (in each group 18). Pilates training sessions will take 3 consecutive 60-minute sessions every week for eight weeks. There is no intervention in the control group. Attitudes to diabetes and quality of life are measured and recorded before and one week after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017040833311N1
Registration date: 2017-07-28, 1396/05/06
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-28, 1396/05/06
Registrant information
Name
Niloofar Hassani
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8590
Email address
n.hasani@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahed University
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pilates training on attitude and quality of life in older women with diabetes mellitus type II Diabetes
Public title
Check Pilates training on attitude and quality of life in elderly women with diabetes mellitus type II
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having at least 60 years of age; ability to respond to the questionnaire; having no history of Pilates exercises before and after entering the research; not having a history of acute heart disease and uncontrolled blood pressure; having no motor or joint problem; having no problem Sight, hearing and cognition (Obtaining a score of at least 7 from the AMTS questionnaire); Ability to do daily activities independently; at least one year of diabetes; the desire of the elderly to participate in research and the signing of consent; the approval of the physician to participate in Pilates exercises. Exclusion criteria: Failure to perform exercises and physical harm, including pain, Frequent blood glucose loss while exercising, with the opinion of a partner physician in the study; Missing more than two sessions about participating in Pilates exercises; Refraining from continuing to collaborate with the research.
Age
From 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahed University Ethics Committee
Street address
Shahed University,In Fron of Holy Shrine of Imam Khomeini, Tehran-Qom Freeway Tehran, Iran.
City
Tehran
Postal code
3319118651
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.Shahed.REC.1395.200

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10,E14
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Attitudes to diabetes
Timepoint
Before and one week after the intervention.
Method of measurement
Diabetes Attitude Scale DAS-3

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and one week after the intervention.
Method of measurement
Quality of life assessment questionnaire dedicated CASP19

Intervention groups

1

Description
The control group received routine care clinic will be used for eight weeks.
Category
Other

2

Description
The intervention group program is as follows: exercises for eight weeks and three sessions per week, 60 minutes each session in two groups of 9 people, set up in a suitable indoor area for exercise, and auxiliary equipment for the safety of the elderly Including fences, chairs and flooring will be considered appropriate. It should be noted that the exercises are per-trained by the researcher and will be initially taught and supervised by a pediatric-educated expert in Pilates exercises.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic Hussein
Full name of responsible person
Niloofar Hassani
Street address
Between 14st and 15st Alley, Hafte tir St, Saeedi Sq , Qom
City
Qom

2

Recruitment center
Name of recruitment center
Clinic Baqiyatallah
Full name of responsible person
Niloofar Hassani
Street address
7st Alley , martyr Fatemi Ave, Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University Vice chancellor for research
Full name of responsible person
Dr. Parvin Rahnama
Street address
Shahed University,In Fron of Holy Shrine of Imam Khomeini, Tehran-Qom Freeway Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr.Majideh Heravi
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University,In Fron of Holy Shrine of Imam Khomeini, Tehran-Qom Freeway Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6641 8590
Fax
+98 21 6641 8580
Email
Majdehheravi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Majide Heravi
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University,In Fron of Holy Shrine of Imam Khomeini, Tehran-Qom Freeway Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6641 8590
Fax
+98 21 6641 8580
Email
majdehheravi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery Faculty of Amol
Full name of responsible person
Dr. Seyed Hamid Sharifnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Paramedical, Faculty of Nursing and Midwifery , Fayyaz bakhsh St , Taleb Amoli Ave, Amol
City
Amol
Postal code
Phone
+98 12 1222 1919
Fax
Email
h.sharifnia@mazums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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