Protocol summary

Study aim
Investigating the effect of recreational tennis table on the bone health, body composition, lipid profiles and physical function of older men.
Design
The present research is a randomized, controlled, prospective clinical trial with parallel groups. The population of the study consisted of elderly people in Shahrood.The subjects of the study are 40 older adults with table tennis experience that selected on the basis on inclusion and exclusion criteria. Participants are enrolled by one of the research colleagues. An independent assessor, blinded person who had no further involvement in the study made a random allocation sequence using a computer Software prior to the initiation of the study that was used to randomize participants with 1:1 allocation ratio in control group (n=20) and table tennis group (n=20). A block randomization design (block size of 2, 4) were applied to ensure an equal number of participants in each group. Group allocation was concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes were opened after enrolled participants completed all baseline assessments.
Settings and conduct
The location of this research is at Nursing homes and community of Shahroud. As it is impossible to blind, participants and sport science specialist providing the tennis table training were not blinded to group allocation. Laboratory specialists assessing the variables and data analyst were blinded to the allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 60 years; Independent living in the community; Lack of regular participation in other physical activities (such as walking, fitness classes); Last participate in table tennis for more than 5 years ago; Ensuring of participants safety during physical activity based on Physical Fitness Readiness Questionnaire; Independence in daily life activities; Physician certification for participation in the study; Signing a confirmation form for informed participation in the research. Exclusion criteria: History of bone metabolic disease and corticosteroids consumption; history of severe musculoskeletal disorders (such as lower back , knee or hip joint arthritis) and / or arthroscopy and artificial implants; history of neurological complications/problems (such as Parkinson's disease, stroke, spinal cord injury and cerebral palsy); history of endocrine disorders such as hypothyroidism and hyperthyroidism.
Intervention groups
Table Tennis Group: This group receives a 24-week table tennis training program that runs three sessions each week for a period of 1.5 hours in each session. Control group: During the duration of the this research, they continue their usual routine activities.
Main outcome variables
Bone density; Body composition; Lipid profile; Physical Function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170114031942N4
Registration date: 2018-02-25, 1396/12/06
Registration timing: registered_while_recruiting

Last update: 2018-02-25, 1396/12/06
Update count: 0
Registration date
2018-02-25, 1396/12/06
Registrant information
Name
Aynollah Naderi
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 917 721 7462
Email address
ay.naderi@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Recreational Table Tennis on an Bone Health, Body composition, Lipid Profile and Physical Function in Older Men
Public title
Recreational Table Tennis and Physical Health of Older Men
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years; Independent living in the community; Lack of regular participation in other physical activities (such as walking, fitness classes); Last participate in table tennis for more than 5 years ago; Ensuring of participants safety during physical activity based on Physical Fitness Readiness Questionnaire; Independence in daily life activities; Physician certification for participation in the study; Signing a confirmation form for informed participation in the research.
Exclusion criteria:
History of bone metabolic disease and corticosteroids consumption; history of severe musculoskeletal disorders (such as lower back , knee or hip joint arthritis) and / or arthroscopy and artificial implants; history of neurological complications/problems (such as Parkinson's disease, stroke, spinal cord injury and cerebral palsy); history of endocrine disorders such as hypothyroidism and hyperthyroidism.
Age
From 60 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are enrolled by one of the research colleagues. An independent assessor, blinded person who had no further involvement in the study made a random allocation sequence using a computer Software prior to the initiation of the study that was used to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 2, 4) were applied to ensure an equal number of participants in each group. Group allocation was concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes were opened after enrolled participants completed all baseline assessments. As it is impossible to blind, participants and sport science specialist providing the tennis table training were not blinded to group allocation. Laboratory specialists assessing the variables and data analyst were blinded to the allocation.
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
دانشگاه علوم پزشکی شاهرود
Street address
Semnan Province, Shahroud, shahroud medical university
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.SHMU.REC.1396.167

Health conditions studied

1

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

Primary outcomes

1

Description
Bone density
Timepoint
Before starting the study and after completing the study
Method of measurement
dual-energy X-ray absorptiometry (DXA)

2

Description
Body composition
Timepoint
Before starting the study and after completing the study
Method of measurement
dual-energy X-ray absorptiometry (DXA)

3

Description
Lipid profile
Timepoint
Before starting the study and after completing the study
Method of measurement
Blood sampling

4

Description
Physical Function
Timepoint
Before starting the study and after completing the study
Method of measurement
Static balance by FICSIT-4, dynamic balance by the dynamic walking index and physical performance by the short physical performance battery will be evaluated .

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Perform a 24-week table tennis training that runs three times a week And the duration of each session will be 1.5 hours.
Category
Prevention

2

Description
Control group: Continuing the activities of daily living
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nursing homes in the city
Full name of responsible person
Aynollah Naderi
Street address
Shahrood University of Technology, Tehran Road
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Technology
Full name of responsible person
Aynollah Naderi
Street address
Tehran avenue, Shahroud, Semnan province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
ay.naderi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Technology
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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