1. Home
  2. Approved trials
  3. » فارسی

The effect of corrective exercise with massage on balance, motor function, gait and quality of life of the elderly male with hyperkyphosis

Protocol summary

Study aim
The aim of this study is the effect of corrective exercises with massage on balance, motor performance, walking and quality of life of elderly men with hyperkyphosis
Design
A randomized clinical trial study, a single-blind, factorial strain, 30 elderly people have been divided into an intervention group and a control group, through web randomization
Settings and conduct
The participants were equally divided into two groups of corrective exercises with massage and the control group.This study was conducted in Sabzevar city and Khoshab district. The importance of the sports program will be explained to the participants. The exercises are for 8 weeks and three sessions a week
Participants/Inclusion and exclusion criteria
Entry conditions:hyperkyphosis above 40 degrees, age between 65 and 74 years,, not consuming Tranquilizers or any special medicine affecting balance, not having any neurological, severe respiratory, vascular, metabolic and uncontrollable musculoskeletal diseases, not having any severe and serious visual or hearing disorders.Conditions of non-entry: major psychiatric illness, cognitive impairment, alcohol or drug abuse, the presence of any physical defects affecting balance activities, the presence of joint sprains, the presence of hip, knee and ankle joint surgery, the presence of heart diseases. - acute respiratory, presence of chronic diseases of the motor system (joint rheumatism, chronic arthritis and osteoporosis) (confirmed by a specialist doctor)
Intervention groups
Intervention group: Corrective exercises and massage therapy were considered for each subject and three sessions were held for 8 weeks. the duration of each session was 6 min, including 10 minutes of warming up and cooling down. Control group: no activity during 8 weeks of the training program.
Main outcome variables
Kyphosis degree, balance, movement performance, walking kinematics and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220919055988N1
Registration date: 2022-11-28, 1401/09/07
Registration timing: retrospective

Last update: 2022-11-28, 1401/09/07
Update count: 0
Registration date
2022-11-28, 1401/09/07
Registrant information
Name
Abolfazl Tarkhasi
Name of organization / entity
The University of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 51 4429 2661
Email address
abolfazltarkhaasiy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-22, 1401/04/31
Expected recruitment end date
2022-08-05, 1401/05/14
Actual recruitment start date
2022-07-31, 1401/05/09
Actual recruitment end date
2022-08-20, 1401/05/29
Trial completion date
empty
Scientific title
The effect of corrective exercise with massage on balance, motor function, gait and quality of life of the elderly male with hyperkyphosis
Public title
The effect of corrective exercise with massage on balance, motor function, gait and quality of life of the elderly male with hyperkyphosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hyperkyphosis above 40 degrees Age range from 65 to 74 years The ability to stand for at least 1 minute and walk 10 meters or more independently or with a regular cane. The doctor's permission to participate in this study and the ability to perform corrective movements. Not taking sedatives or any special medicine affecting balance Not having any uncontrollable neurological, severe respiratory, vascular, metabolic and musculoskeletal diseases Not having any severe and serious visual or hearing impairment
Exclusion criteria:
Major psychiatric disease, cognitive disorder Alcohol or drug abuse The presence of any physical defect affecting balance activities Having a history of sprained joints, having a history of hip, knee and ankle joint surgery Presence of acute cardio-respiratory diseases Existence of chronic diseases of the motor system (joint rheumatism, chronic arthritis and osteoporosis) (confirmed by a specialist doctor)
Age
From 65 years old to 74 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized into two groups (one intervention and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport Sciences Research Institute (SSRI)
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2022-07-20, 1401/04/29
Ethics committee reference number
IR.SSRC.REC.1401.042

Health conditions studied

1

Description of health condition studied
Hypokyphosis
ICD-10 code
M40
ICD-10 code description
Kyphosis and lordosis

2

Description of health condition studied
strengthening exercises
ICD-10 code
Y93.B9
ICD-10 code description
Activity, other involving muscle strengthening exercises

Primary outcomes

1

Description
kyphosis status: In this study, the outcome of the first variable is the reduction of the kyphosis angle
Timepoint
Measurement of thoracic kyphosis at the beginning of the study (pre-test), measurement again at the end of the study (post-test)
Method of measurement
Flexible ruler

Secondary outcomes

1

Description
dynamic balance
Timepoint
At the beginning of the study (before the start of the intervention), (pre-test), and at the end of the intervention, (post-test)
Method of measurement
In this research, dynamic balance during movement will be measured by TUG.

2

Description
Motor performance factor
Timepoint
At the beginning of the study, before the intervention (pre-test), at the end of the intervention (post-test)
Method of measurement
6-minute walking test to measure motor performance

3

Description
walking item
Timepoint
At the beginning of the study, before the intervention (pre-test), at the end of the intervention (post-test
Method of measurement
2D imaging for gait assessment

4

Description
Quality of life factor
Timepoint
At the beginning of the study, before the intervention (pre-test), at the end of the intervention (post-test)
Method of measurement
The SF_36 questionnaire was used to evaluate the quality of life.

5

Description
Static balance
Timepoint
At the beginning of the study, before the intervention (pre-test), at the end of the intervention (post-test)
Method of measurement
Sharpendermberg test to measure static balance.

Intervention groups

1

Description
Intervention group: Corrective exercises and massage therapy were considered for each subject and three sessions were held for 8 weeks. the duration of each session was 6 min, including 10 minutes of warming up and cooling down.
Category
Rehabilitation

2

Description
Control group: without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Farazmehr physiotherapy and hydrotherapy
Full name of responsible person
Samane Farazmehr
Street address
No. 57, 2 Khorramshahr Alley, Bahar St., Sabzvar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613984371
Phone
+98 51 4423 0381
Email
s.farazmehr@gmail.come

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr Mohammad Delnavaz
Street address
KhU, No. 43. South Mofatteh Ave., Tehran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8832 9220
Email
info@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi University
Proportion provided by this source
100
Public or private sector
Public
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
Kharazmi University
Full name of responsible person
Hassan Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 43. South Mofatteh Ave., Tehran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8832 9220
Email
Hassan.sadeghi81@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Malihe Hadadnezhad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 43. South Mofatteh Ave., Tehran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8832 9220
Email
m.hadadnezhad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Abolfazl tarkhasi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Pathology and corrective exercise
Street address
No. 60, 34 Bahner Alley, Bahner Blvd., 2nd forty meters
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619836676
Phone
+98 51 4429 2661
Email
abolfazltarkhaasiy@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
Loading...