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The effect of a combined training session on cardiorespiratory fitness , motor control , congnitive function , balance , walking performance and postural control in active elderly men

Protocol summary

Study aim
The purpose of the present study was to investigate the effect of a combined training session on cardiopulmonary fitness, motor control, cognitive function, balance , walking performance and postural control in elderly active men
Design
In the present study, experimental and control groups, which were divided into simple random sampling, performed their own exercises for 8 weeks.
Settings and conduct
Semi-experimental and in one of the parks of Lahijan city
Participants/Inclusion and exclusion criteria
Entry requirements: 60 to 70 years old men; be healthy based on a health questionnaire and confirmation by a doctor; regular exercise history; BMI between 20 and 29; ability to follow instructions by the examiner and complete the questionnaire. No entry conditions: tobacco and alcohol consumption; failure to attend more than two sessions; having chronic and specific diseases; lack of health approval by a doctor; having mental illness and taking psychotropic drug.
Intervention groups
Intervention group: combined exercise group for eight weeks, three sessions per week. Aerobic exercise with 50 to 70% intensity of maximum heart rate, 15 to 30 minutes, weight-bearing resistance training, 3 sets of 15 repetitions for 10 to 15 minutes, balance training for 5 to 10 minutes. The control group continues its sports activities without the intervention of the researcher.
Main outcome variables
Cardiac readiness, pulmonary function, motor control, cognitive function, balance, walking performance and postural control

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150531022498N32
Registration date: 2020-05-28, 1399/03/08
Registration timing: retrospective

Last update: 2020-05-28, 1399/03/08
Update count: 0
Registration date
2020-05-28, 1399/03/08
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-17, 1398/07/25
Expected recruitment end date
2019-12-25, 1398/10/04
Actual recruitment start date
2019-10-17, 1398/07/25
Actual recruitment end date
2019-12-25, 1398/10/04
Trial completion date
2020-01-05, 1398/10/15
Scientific title
The effect of a combined training session on cardiorespiratory fitness , motor control , congnitive function , balance , walking performance and postural control in active elderly men
Public title
Effect of combined exercise training in active elderly men
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
60 to 70 years old men Be healthy based on a health questionnaire and confirmation by a doctor Regular exercise history It has a BMI between 20 and 29 Ability to follow instructions by the examiner and complete the questionnaire
Exclusion criteria:
Tobacco and alcohol consumption Failure to attend more than two sessions Having chronic and specific diseases Lack of health approval by a doctor Having mental illness and taking psychotropic drugs
Age
From 60 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty active elderly were selected as participants in the research process. After the necessary investigations and based on the information of the completed questionnaires, the subjects were divided into two groups of 20 people using a lottery to divide by simple random method.
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 Islamic Azad University, Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.IAU.RASHT.REC.1399.015

Health conditions studied

1

Description of health condition studied
Active older men
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Heart rate
Timepoint
Before and after the intervention
Method of measurement
Record blood pressure and heart rate before and immediately after the rockport test

2

Description
Pulmonary function
Timepoint
Before and after the intervention
Method of measurement
A spirometer was used to measure the amount of lung variable volume during respiratory maneuvers.

3

Description
Static motor control
Timepoint
Before and after the intervention
Method of measurement
Static motor control was measured using a stabillometer .

4

Description
Static balance
Timepoint
Before and after the intervention
Method of measurement
Static balance was measured using a stabillometer .

5

Description
Static postural control
Timepoint
Before and after the intervention
Method of measurement
Static postural control was measured using a stabillometer .

6

Description
Walking performance
Timepoint
Before and after the intervention
Method of measurement
This test consists of 10 parts. Subjects had to perform a total of 10 items over a distance of 6 meters and a width of 30 centimeters according to the instructions given, which include:1- Walking level, 2- Change in walking speed, 3- Walking with horizontal rotation of the head,4- Walking with vertical rotation of the head, 5- Walking and pelvic rotation, 6- Walking so that it is an obstacle in the middle of the road,7- Walking with a low reliability level, 8- Walking with your eyes closed, 9- Moving backwards, 10- Climbing stairs.

7

Description
Cognitive function
Timepoint
Before and after the intervention
Method of measurement
In this test, 8 cognitive domains were measured through various skills including executive performance, naming, memory, language, abstraction, short-term memory, and awareness of time and place.

Secondary outcomes

1

Description
Body composition
Timepoint
Before and after the intervention
Method of measurement
Using weight, body mass index, waist to hip ratio and fat percent

Intervention groups

1

Description
Intervention group: combined exercise group for eight weeks, three sessions per week. Aerobic exercise with 50 to 70% intensity of maximum heart rate, 15 to 30 minutes, weight-bearing resistance training, 3 sets of 15 repetitions for 10 to 15 minutes, balance training for 5 to 10 minutes.
Category
Other

2

Description
Intervention group: This group performs light aerobic exercise three days a week for 8 weeks, including 15 minutes of walking and 10 aerobic movements with 50 to 60% of maximum maximum heart rate
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahan Talent Center
Full name of responsible person
Mina Safari
Street address
Lahijan, Chai Square, Jomhuri St.
City
Lahijan
Province
Guilan
Postal code
4414746797
Phone
+98 13 4233 6067
Email
minasafari04@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali delpasand
Street address
Islamic Azad University, Rasht Brunch
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
shabani_msn@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Azad University, Rasht Branch
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Azad University, Rasht Branch
Full name of responsible person
Mina Safari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physical Education
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
minasafari04@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Azad University, Rasht Branch
Full name of responsible person
Ramin Shabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Lakan St., Poltaleshan Blv. , Rasht, Gilan, Iran
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
shabani_msn@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Azad University, Rasht Branch
Full name of responsible person
Mina Safari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physical Education
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
minasafari04@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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