Protocol summary

Study aim
ّIn this study we sought to evaluate the effectiveness of 6 weeks of online corrective exercises on posture, disability, respiratory function, and quality of life in the elderly with thoracic hyperkyphosis
Design
A clinical trial with the control group, With parallel groups, single-blinded, randomized
Settings and conduct
34 elderly adults with thoracic hyperkyphosis will recruit and randomly assign to two control and experimental groups. All measurements will perform in the biomechanics laboratory of the faculty of physical education at Allame Tabataba'i University.
Participants/Inclusion and exclusion criteria
Adults aged ≥60 with TK angle more than 40◦, without participation in any regular exercise routines were included in this study. The exclusion criteria were the history of any neuromuscular diseases, presence of back pain, osteoarthritis, falls while walking, cancers and chemotherapy, long-term use of corticosteroids medication,
Intervention groups
The experimental group will undergo the corrective exercises protocols with online supervision for 6 weeks (3 sessions per week ×60 minutes), which will be augmented with breathing practices. Exercises will be used as part of the intervention to address issues with spinal extensor muscle weakness, inadequate recruitment and activation of the muscles, limited spinal mobility, and improper postural alignment. The control group will be asked to perform 10 minutes of general warm-up exercises and general stretching exercises followed by 40 minutes of self-selected walking speed.
Main outcome variables
Quality of life (SF 36) Postural measurements (Kyphosis angle, forward head posture angle, shoulder angle) Disability Index (Barthel Index) Breathing pattern

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180626040244N3
Registration date: 2022-10-08, 1401/07/16
Registration timing: prospective

Last update: 2022-10-08, 1401/07/16
Update count: 0
Registration date
2022-10-08, 1401/07/16
Registrant information
Name
Rahman Sheikhhoseini
Name of organization / entity
Allameh Tabataba'i University
Country
Iran (Islamic Republic of)
Phone
+98 21 4839 4134
Email address
rahmanhoseini@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of online respiratory and corrective exercises on posture, physical ability, respiratory function, and quality of life in the elderly with thoracic hyper-kyphosis
Public title
The effect of online rcorrective exercises in the elderly with thoracic hyper-kyphosis: A clinical trial study
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged ≥60 Thoracic kyphosis angle more than 40◦ Without participation in any regular exercise routines
Exclusion criteria:
History of any neuromuscular diseases Presence of back pain History of osteoarthritis History of falls while walking History of cancers and chemotherapy History of long-term use of corticosteroids medication Age more than 75 years
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done as simple method with card. The type of intervention will be put in sealed envelopes. Individuals are listed in order of attendance. After including in the study, the envelops will shuffled and each person is asked to select an envelope. The subjects will be asked to select one envelope. According to the predicted sample size, the number of envelope will be provided. Therefore, any selected envelope will not return to randomization sequence. This type of randomization can result to have the same number of individuals in both groups.
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
Allameh Tabataba'i University
Street address
Chogan street
City
Tehran
Province
Tehran
Postal code
1485743411
Approval date
2021-05-22, 1400/03/01
Ethics committee reference number
IR.ATU.REC.1400.012

Health conditions studied

1

Description of health condition studied
Thoracic hyper kyphosis
ICD-10 code
M40.03
ICD-10 code description
Postural kyphosis, cervicothoracic region

Primary outcomes

1

Description
Quality of life
Timepoint
Before the study starts and after 6 weeks of intervention
Method of measurement
SF-36 questionnaire

2

Description
Posture
Timepoint
Before the study starts and after 6 weeks of intervention
Method of measurement
photogrametric method

3

Description
Physical ability
Timepoint
Before the study starts and after 6 weeks of intervention
Method of measurement
Barthel index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: online respiratory and corrective exercises including stretching and strengthening, for 6 weeks, 3 sessions per week, every session last for 60 minuets,
Category
Prevention

2

Description
Control group: general walking for 60 minuets, 3 sessions per week with self-selected speed
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Tabataba'i University
Full name of responsible person
Rahman Sheikhhoseini
Street address
Chogan street
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4411 8629
Email
rahmanhoseini@atu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Rahman Sheikhhoseini
Street address
Chogan street
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4411 8629
Email
rahmanhoseini@atu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i 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
Allameh Tabataba'i University
Full name of responsible person
Rahman Sheikhhoseini
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Chogan street
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4411 8629
Email
rahmanhoseini@atu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Rahman Sheikhhoseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Sport Sciences, AllamehTabataba'i University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4839 4134
Fax
Email
rahman.pt82@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Rahman Sheikhhoseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Sport Sciences, AllamehTabataba'i University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4839 4134
Fax
Email
rahman.pt82@gmail.com

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 further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All primary and secondary data will be share in the future after making them unidentifiable
When the data will become available and for how long
Data will be available immediately after publishing the study results
To whom data/document is available
All academic people and researchers
Under which criteria data/document could be used
Data will be share for systematic review and meta-analyses studies, or for any researchers who need for our data for research proposes
From where data/document is obtainable
Data request can be sent to following Emails: 1. rahman.pt82@gmail.com, 2. hpiry63@gmail.com, and 3. rahmanhoseini@atu.ac.ir
What processes are involved for a request to access data/document
All requests will be answered immediately after receiving Emails, for maximum of 1 week
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