Protocol summary

Summary
The objective of this randomized single blind trial is to compare the effects of strengthening and dynamic balance exercise on dynamic balance in healthy young-old people. in this study, 90 healthy old people (55 to 75 years old), randomly assigned into three groups. 1) strengthening exercise group, 2) dynamic balance exercise group, 3) control group. Subjects in strengthening group, do resistance training (6 exercises, 3 times a week, for 6 weeks) in lower extremity with elastic tube in three sets (10 repetitions). subjects in balance group, do jumping training on mini trampoline for 5 minutes (3 times a week, for 6 weeks). Control group wont receive any interventions. changes of the average actual score, standard deviation of postural sway and falling risk, will be measured before intervention, after intervention and after one month follow up and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050722143N1
Registration date: 2015-08-01, 1394/05/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-01, 1394/05/10
Registrant information
Name
Raziyeh Ebrahimi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3621 1881
Email address
rebrahimi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-05-05, 1394/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effects of strengthening and dynamic balance exercise on dynamic balance in healthy young-old people
Public title
effects of balance exercise on balance
Purpose
Other
Inclusion/Exclusion criteria
inclusion criteria: Category 55-75 years of age (young old: According to the World Health Organization); the ability to walk at least 10 meters independently (without means of assistance); the ability to stand on one foot for at least 5 seconds. Exclusion criteria: items that can put health at serious risk such as: A history of heart Stroke during the last 6 months; weakness in the control of high blood pressure (blood pressure above than 160 on 90 milimeters of mercury); factors that ambiguity can be achieved include: diabetic neuropathy; a history of vascular lesions (stroke); acute and chronic cardiopulmonary system failure; lower extremity joint replacement; any cognitive deficits that interfere with the recipe, such as: Dementia; a history of medication associated with disease of the lower extremities and back; Any disease of the central nervous system; peripheral nervous system; vestibular system and uncorrectable visual impairment; orthostatic hypotension; well-known drugs that can affect balance, such as: neuroleptic benzodiazepines or other drugs that are known to improve strength, such as: prednisone.
Age
From 54 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy of Research, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Deputy of Research, Bassij Blvd, Semnan, Iran.
City
Semnan
Postal code
351313811
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
93/584681

Health conditions studied

1

Description of health condition studied
Falls
ICD-10 code
R 29.6
ICD-10 code description
Tendency to fall, not elsewhere classified

Primary outcomes

1

Description
actual score
Timepoint
before intervention, after 18 sessions of intervention and after 1 month follow up
Method of measurement
falling risk test/ biodex stability system

2

Description
standard deviation of postural sway
Timepoint
before intervention, after 18 sessions of intervention and after 1 month follow up
Method of measurement
falling risk test/ biodex stability system

Secondary outcomes

1

Description
Balance
Timepoint
before intervention,after 18 sessions of intervention and after 1 month follow up
Method of measurement
total score of 14 functional balance test

Intervention groups

1

Description
Intervention: 5 minutes warm up (with gentle stretching exercise in lower extremity), strengthening exercise in lower extremity in 3 set (10 repetitions), 3 times a week, for 6 weeks (18 sessions)
Category
Rehabilitation

2

Description
intervention: 5 minutes warm up with gentle stretching exercise in lower extremity, 5 minutes jumping on mini trampoline, 5 minutes cool down with gentle stretching exercise in lower extremity, 3 times a week, for 6 weeks (18 sessions).
Category
Rehabilitation

3

Description
control: without intervention
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Dr. Mohamad Amuzade KHalili
Street address
Semnan, Qods Street, across the Red Crescent Center, Neuromuscular Rehabilitation Research Center
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research- Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidipour
Street address
Semnan University of Medical Sciences, Deputy of Research, Bassij Blvd, Semnan, Iran.
City
Semnan
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- Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Dr.Mohamad Amuzade Khalili
Position
Ph.D of Physiotherapy/ Professor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Kilometer 5 Damghan road
City
Semnan
Postal code
Phone
+98 233365418000
Fax
Email
moh35ir@yahoo.co.uk
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohamad Amuzade Khalili
Position
Ph.D of Physiotherapy/ Professor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Kilometer 5 Damghan road
City
Semnan
Postal code
Phone
+98 23 3364 4180
Fax
Email
moh35ir@yahoo.co.uk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohamad Amuzade Khalili
Position
Ph.D of Physiotherapy/ Professor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Kilometer 5 Damghan road
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
moh35ir@yahoo.co.uk
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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