Protocol summary

Summary
Objectives: The aim of this study was to investigate the effect of strength exercise with elastic band on geriatric morale. Design: This study was a randomized clinical trial with two groups (experimental and control), pre and post-test design, and not-blinded. Setting and conduct: This study was conducted on 70 elder who referred to Adviehchi and Bafti health Center of Mashhad that were randomly divided into two groups (n = 35). Participants: Inclusion criteria: Over 60 years old. Exclusion criteria: Withdraw from the study for any reason. Intervention: in experimental group was conducted exercise for 6 weeks (2 sessions per week) and elders in control group were continued to usual activities. The main outcome variables in this study included: geriatric morale that in both groups was assessed before the intervention and the end of sixth week with Philadelphia Geriatric Center Morale Scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031227741N2
Registration date: 2017-04-07, 1396/01/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-07, 1396/01/18
Registrant information
Name
Sedigheh Arta
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 32566747
Email address
artas1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2016-12-15, 1395/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the Effect of Strength Exercise with Elastic Band and Common Exercise on Geriatric Morale
Public title
The Effect of Exercise on Geriatric Morale
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; Over 60 years old. Exclusion criteria: Withdraw from the study for any reason.
Age
From 60 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The elders divided to intervention and control group with simple randomization method (lottery).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Postal code
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.MUMS.REC.94.356

Health conditions studied

1

Description of health condition studied
Morale
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Morale
Timepoint
Before the intervention and the end of sixth week
Method of measurement
Philadelphia Geriatric Center Morale Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in intervention group, exercise was conducted for 6 weeks (2 sessions per week) in the coliseum.
Category
Prevention

2

Description
Control group: in control group, elders were continued to usual activities.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Adviehchi Health Center
Full name of responsible person
Elham Rezaee
Street address
Elder Department, Daneshamouz Health Center, Ebne Sina St, Imam Reza Square, Mashhad
City
Mashhad

2

Recruitment center
Name of recruitment center
Bafti Health Center
Full name of responsible person
Nahid Ebrahimi
Street address
Elder Department, Emamat Health Center, Ayatolah Bahjat St, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice chancellor for research, Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, 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
School of Nursing and Midwifery
Full name of responsible person
Fatemeh Pourtaghi
Position
Master of Science Student in Gerontology
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3607 8926
Fax
Email
Pourtaghif1@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Zahra Emami Moghadam
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3852 8512
Fax
Email
EmamimoghadamZ@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Fatemeh Pourtaghi
Position
Master of Science Student in Gerontology
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3607 8926
Fax
Email
Pourtaghif1@mums.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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