Protocol summary

Summary
Objectives: The aim of this study was to compare the effect of water-based and land-based exercises on bio-motor capabilities of elder men's. Design: This study was a randomized clinical trial with two groups (water and land-based exercises), pre and post-test design, and not-blinded. Setting and conduct: This study was conducted on 60 elder men who referred to Emamat and Daneshamouz health Center of Mashhad that were randomly divided into two groups (n = 30). Participants: Inclusion criteria: Over 60 years old. Exclusion criteria: Having the cardiac disease. Intervention: in experimental group (water-based exercises) was conducted exercise for 6 weeks (3 sessions per week) in the baths and in control group (land-based exercises) was conducted for this period in the coliseum, too. The main outcome variables in this study included: bio-motor capabilities of elder men's that in both groups was assessed before the intervention and the end of sixth week with bio-motor capabilities researcher-made questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101824845N3
Registration date: 2017-01-12, 1395/10/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-12, 1395/10/23
Registrant information
Name
Akhtar Nejat Mohammad
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3523 2319
Email address
nejatma1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the Effect of Water and Land-based Exercises on Bio-Motor Capabilities of Elder Men
Public title
The Effect of Exercise on Bio-motor Capabilities of Elders
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; Over 60 years old. Exclusion criteria: Having the cardiac disease.
Age
From 60 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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 (water-based exercises) and control (land-based exercises) group with simple randomization method.

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
2016-02-29, 1394/12/10
Ethics committee reference number
IR.MUMS.REC.94.877

Health conditions studied

1

Description of health condition studied
Bio-motor Capabilities
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Bio-motor capabilities
Timepoint
Before the intervention and the end of sixth week
Method of measurement
Bio-motor capabilities researcher-made questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in intervention group, exercise was conducted for 6 weeks (3 sessions per week) in the baths.
Category
Prevention

2

Description
Control group: in control group, exercise was conducted for 6 weeks (3 sessions per week) in the coliseum, too.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Daneshamouz 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
Emamat 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
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
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
Mojtaba Askari
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
Askarim1@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
Seyed Reza Mazloum
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
Mazlomr@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
Mojtaba Askari
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
00
Fax
Email
Askarim1@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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