Protocol summary

Summary
Objective of the study: The effect of balance, strength and combined training on balance in elderly women Study design: randomized, not blinded, no placebo. Study population: elderly women of tehran province. Inclusion criteria: ages between 60 to 70 years old; having no joint dislocation or chronic arthritis problem. Exclusion criterion: having any type of pain in knee and ankle during training. Sample size: 24 people. Interventions studied: balane, strength and combined (balance and strength) training. Intervention period: 6 weeks, 3 sessions per week. Study outcome: Balance (overall, anterio-posterior, medial-lateral) that measured before and 6 weeks after implementation

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014070718386N1
Registration date: 2014-07-26, 1393/05/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-26, 1393/05/04
Registrant information
Name
Parisa Baraz
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 4472 8610
Email address
p_baraz1366@yahoo.com
Recruitment status
Recruitment complete
Funding source
Faculty of physical education and sport science of Shahid Beheshti university
Expected recruitment start date
2013-04-09, 1392/01/20
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of balance, strength and combined training on balance in elderly women
Public title
The effect of training on balance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Age between 60 to 70 years old; 2. Getting the score of 24 or higher in the Mental Status test (MMSE); 3. Ability to stand on their feet for at least one minute; 4. Having no damage in the lower limbs; 5. Having no joint dislocation or chronic arthritis problem; 6. Having no resistance training for 2 years. Exclusion criterion: Having any type of pain in the knee and ankle during training.
Age
From 60 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
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
Shahid Beheshti University
Street address
Shahid Beheshti University, Evin, Tehran
City
Tehran
Postal code
Approval date
2012-08-19, 1391/05/29
Ethics committee reference number
15655

Health conditions studied

1

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

Primary outcomes

1

Description
Balance (overall, anterior-posterior, medial-lateral)
Timepoint
Before and 6 weeks after implementation
Method of measurement
Using the biodex balance system

Secondary outcomes

1

Description
Strength in both knee and ankle joints
Timepoint
Before and 6 weeks after implementation
Method of measurement
Using the isokinetic system

Intervention groups

1

Description
The intervention included training in three balance, strength and combined groups. Training was 6 weeks, 3 session per week. Balancing group performed their workouts using the biodex balance system and weight bearing training variable in the form of four 80-second efforts with 50 seconds reset between each attempt. Stability level of the device, from the first to the sixth session was on level 11, from the seventh to the twelfth sessions was on level 8 and from thirteenth to eighteenth sessions was on level 6. Strengthening group did their workout using isokinetic system in the form of isokinetic contractions in both knee and ankle joints, the knee contracture was done in the form of 4 attempts of 8 repetitions with speed of 60 degrees per second, and 60 seconds rest between every effort and the contracture of ankle joint in the form of 4 efforts of 8 repetitions with the speed of 30 degrees per second with 60 second rest between the efforts. The speed of the device from the first to sixth sessions for the knee joint was 60 and for the ankle joint was 30 degrees per second, from the seventh to the twelfth session for the knee was 75 and for the ankle was 45 degrees per second, and from thirteen to eighteen sessions for knee joint was 90 and for the ankle was 60 degrees per second. All contraction in both joint were concentric. Combined group did their exercises using the biodex balance system and isokinetic system which were in the form of %25 balance training and %75 strength training. Balancing exercises included one 80-second effort and strengthening training in knee joint included three efforts of 8 repetitions with the speed of 60 degrees per second and 60 seconds rest between each effort, and in the ankle joint was in the form of three attempts of 8 repetition with the speed of 30 degrees per second and 60 second rest between each effort and increase of the stability of the balancing system and the speed of isokinetic device in sessions was the same as balancing and strengthening groups. Combined training group, first performed balancing exercises and then strengthening exercises in each session.
Category
Prevention

2

Description
This study having no control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velenjak Neighborhood House
Full name of responsible person
Faghihi Susan
Street address
Velenjak Neighborhood House, Velenjak
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vic president research of Faculty of physical education and sport science of shahid beheshti univers
Full name of responsible person
Dr. Fariborz Hovanloo
Street address
Tehran. evin. shahid beheshti university
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic president research of Faculty of physical education and sport science of shahid beheshti univers
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 Beheshti University
Full name of responsible person
Parisa Baraz
Position
Master of science/ graduate
Other areas of specialty/work
Street address
Shahid Beheshti University, Evin
City
Tehran
Postal code
Phone
+98 87 2422 6742
Fax
Email
p_baraz1366@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Dr. Alireza Farsi
Position
PhD
Other areas of specialty/work
Street address
Tehran. evin. shahid beheshti university
City
Tehran
Postal code
Phone
+98 21 2243 1963
Fax
Email
a_farsi@sbu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Parisa Baraz
Position
Master of science/ graduate
Other areas of specialty/work
Street address
Shahid Beheshti University, Evin, Tehran
City
Tehran
Postal code
Phone
+98 21 4472 8610
Fax
Email
p_baraz1366@yahoo.com; p_parsafar1366@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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