Protocol summary

Summary
Objective: The purpose of this study is to assess the effect of 8 weeks aquatic and land exercise on postural control and balance recovery strategy and also determine their relation to strength, proprioception and reaction time in elderly men. Design: In this clinical trial, 45 persons will be divided randomly in three groups of aquatic exercise, land exercise and control. Setting and conduct: Aquatic and land exercise groups will participate in training sessions for 8 weeks while the control group will not receive the intervention. Major inclusion and exclusion criteria: Inclusion criteria include: Age between 60 and 70; no specific sport activity during study. Exclusion criteria from the study include: Congenital disorders; previous surgery or injury especially in lower extremities; use of sedative and analgesic drugs that disrupt proprioception and balance (especially 24 hours before the test); non-normal body mass index; specific diseases; use of cane or walker to walk; visual, vestibular and neuromuscular disease; inability to do pre and post intervention tests; doing effective exercises in order to improving balance and no completion of training sessions. Interventions: Aquatic exercise and land exercise. Main outcome variables: Before and after intervention, all subjects will be assessed for postural control, balance recovery strategy, reaction time, strength and proprioception.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016031227022N1
Registration date: 2016-04-24, 1395/02/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-24, 1395/02/05
Registrant information
Name
Ramin Beyranvand
Name of organization / entity
Shahid Bahonar University of Kerman
Country
Iran (Islamic Republic of)
Phone
+98 66 1422 1367
Email address
r_beyranvand@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shahid Bahonar University of Kerman
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks aquatic and land exercise on postural control and balance recovery strategy and determine their relation to strength, proprioception and reaction time in elderly men
Public title
The effect of 8 weeks aquatic and land exercise on postural control and balance recovery strategy in elderly men
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include: Age between 60 and 70; no specific sport activity during study. Exclusion criteria from the study include: congenital disorders; previous surgery or injury especially in lower extremities; use of sedative and analgesic drugs that disrupt proprioception and balance (especially 24 hours before the test); non-normal body mass index; specific diseases; use of cane or walker to walk; visual, vestibular and neuromuscular disease; Inability to do pre and post intervention tests; doing effective exercises in order to improving balance and no completion of training sessions.
Age
From 60 years old to 70 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
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
Ethics committee of Kerman University of Medical Science
Street address
Somayeh Crossroads, Kerman
City
Kerman
Postal code
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.KMU.REC.1394.598

Health conditions studied

1

Description of health condition studied
Falling (Loss of balance)
ICD-10 code
W01
ICD-10 code description
Fall on same level from slipping, tripping and stumbling

2

Description of health condition studied
Falling (Loss of balance)
ICD-10 code
W10
ICD-10 code description
Fall on and from stairs and steps

3

Description of health condition studied
Falling (Loss of balance)
ICD-10 code
W17
ICD-10 code description
Other fall from one level to another

4

Description of health condition studied
Falling (Loss of balance)
ICD-10 code
W18
ICD-10 code description
Other fall on same level

5

Description of health condition studied
Falling (Loss of balance)
ICD-10 code
W19
ICD-10 code description
Unspecified fall

6

Description of health condition studied
Falling (Loss of balance)
ICD-10 code
R29.6
ICD-10 code description
Tendency to fall, not elsewhere classified

7

Description of health condition studied
Falling (Loss of balance)
ICD-10 code
R54
ICD-10 code description
Senility

Primary outcomes

1

Description
Postural control
Timepoint
Before, during (mid test) and after intervention.
Method of measurement
By Biodex

2

Description
Balance recovery strategy
Timepoint
Before, during (mid test) and after intervention.
Method of measurement
By Motion Analysis System

3

Description
Strength
Timepoint
Before, during (mid test) and after intervention.
Method of measurement
By Hand Held Dynamometer

4

Description
Proprioception
Timepoint
Before, during (mid test) and after intervention.
Method of measurement
By Photography

5

Description
Reaction Time
Timepoint
Before, during (mid test) and after intervention.
Method of measurement
By Motion Analysis System

Secondary outcomes

empty

Intervention groups

1

Description
The control group will not receive the intervention
Category
N/A

2

Description
Aquatic exercise group will participate in training sessions for 8 weeks and their status will be evaluated before, during and after intervention.
Category
Prevention

3

Description
Land exercise group will participate in training sessions for 8 weeks and their status will be evaluated before, during and after the intervention.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehr Retirement Home
Full name of responsible person
Mr Soleimani
Street address
Farhangian Cross Road, Jomhouri Eslami Blv, Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shahid Bahonar University of Kerman
Full name of responsible person
Dr Maryam Ehtesham Zadeh
Street address
Shahid Bahonar University, Pajohesh Square, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shahid Bahonar University of Kerman
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
Shahid Bahonar University of Kerman
Full name of responsible person
Ramin Beyranvand
Position
Ph.D Student
Other areas of specialty/work
Street address
Shahid Bahonar University, Pajohesh Square, Kerman
City
Kerman
Postal code
Phone
+98 66 1422 1367
Fax
Email
ramin_beyranvand@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Ramin Beyranvand
Position
Ph.D Student
Other areas of specialty/work
Street address
Shahid Bahonar University, Pajohesh Square, Kerman
City
Kerman
Postal code
Phone
+98 66 1422 1367
Fax
Email
ramin_beyranvand@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Ramin Beyranvand
Position
Ph.D student
Other areas of specialty/work
Street address
Shahid Bahonar University, Pajohesh Square, Kerman
City
Kerman
Postal code
Phone
+98 66 1422 1367
Fax
Email
ramin_beyranvand@yahoo.com
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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