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Trial registered on ANZCTR


Registration number
ACTRN12618001660279
Ethics application status
Approved
Date submitted
23/09/2018
Date registered
8/10/2018
Date last updated
8/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Manual Therapy and Inspiratory Muscle Strength in Apparently Healthy Smokers
Scientific title
Immediate Effect of Thoracic Manual Therapy on Inspiratory Muscle Strength in Apparently Healthy Smokers: A randomized clinical trial.
Secondary ID [1] 296155 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pulmonary function 309850 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308556 308556 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
all intervention and assessment were performed at outpatient physical therapy clinical, rehabilitation health sciences department, college of applied medical sciences, Riyadh , Saudi Arabia.
Subjects in the interventional group were in a supine position and the arms at the side. The physiotherapist who is certified in manual therapy performed the intervention by placing his hands on the lower last four ribs on both sides and the thumb was underneath the both hemidiaphragm just below the xiphoid process of the sternum . The physiotherapist asked the subject to take a deep breath in and out; while the physiotherapist was applying a gentle pressure downward and inward directly to both hemidiaphragm at the same time and maintain this position with the same force for five minutes. This technique was repeated 5 times.
After the diaphragmatic release, the physiotherapist immediately performed the second technique which was a thoracolumbar manipulation. While the subject in the supine position with both arms crossed over the chest, the physiotherapist stood by the side of the subject and placed one hand at the level of thoracolumbar area (T12 and L1 vertebra) and the other hand was over the arms of the subject. The physiotherapist asked the subject to take a deep breath in and out for three times and at the end of the third breath, the physiotherapist performed an anteroposterior thrust force of high-velocity low amplitude at T12 and L1 vertebrae level.
Intervention code [1] 312480 0
Rehabilitation
Comparator / control treatment
Subjects in the placebo group received sham techniques. The physiotherapist placed his hand on the abdomen at the level of umbilical area and asked the subjects to take normal breathing for 5 minutes. During the second technique, the physiotherapist placed one hand underneath the thoracolumbar junction and the other hand was on the chest and asked the subjects to take 3 normal breathing.
Control group
Placebo

Outcomes
Primary outcome [1] 307521 0
Sniff Nasal Inspiratory Pressure

All subjects were seating with back supported and their arms rested on the thighs. After choosing an appropriate nasal probe size and place it inside the nostril, the physiotherapist asked the subject to make a sharp and quick sniff from functional residual capacity (FRC). This procedure was repeated 10 times with 30 seconds' rest between each sniff and the best reading was chosen. The measurement was made at the baseline and immediately after the intervention
Timepoint [1] 307521 0
The measurement was made at the baseline and immediately after the intervention.
Secondary outcome [1] 352194 0
nil
Timepoint [1] 352194 0
nil

Eligibility
Key inclusion criteria
Subjects were recruited if they were healthy smokers with a smoking history of no less than 10 packs per year, and had no previous medical history of cardiopulmonary disease, neuromusculoskeletal disease
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects were excluded if they had a body mass index over 35, pregnant or aged above 35 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were randomized to either intervention or placebo group using a concealed oblique envelope that had prepared by the authors to include cards of both groups (group A= Interventional and group B= Sham group) and shuffled randomly each time.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The statistical software package SPSS 21.0 (Chicago, Illinois, U.S.A.) was used for all analysis. Data were checked for normality prior to analysis. Data were presented as mean and standard deviation. Comparison between pre and post intervention within the subject was performed using paired T-test. Comparison between the groups was performed using independent T test. Relationships between variables were explored using Pearson’s correlation coefficients. For all analysis p<0.05 was considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20863 0
Saudi Arabia
State/province [1] 20863 0
Riyadh

Funding & Sponsors
Funding source category [1] 300746 0
University
Name [1] 300746 0
Deanship of Scientific Research at king Saud University
Address [1] 300746 0
King Saudi Arabia,
king Saud university
deanship of Scientific Research
king Abdullah road , Riyadh
P.O. Box 2454Riyadh 11451
Country [1] 300746 0
Saudi Arabia
Primary sponsor type
Individual
Name
Ali Albarrati
Address
Department of rehabilitation Health Sciences. College of Applied Medical Science, King Saud University, Riyadh Saudi Arabia,
P.O Box 10219, Riyadh 11433
Country
Saudi Arabia
Secondary sponsor category [1] 300283 0
Individual
Name [1] 300283 0
Thamer Alshameri
Address [1] 300283 0
King Abdul-Aziz Medical City in National Guard, Riyadh
Rehabilitation department
P.O.Box 22490RIyadh 11426
Country [1] 300283 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301525 0
CAMS-Research Ethics Committee
Ethics committee address [1] 301525 0
College of Applied Medical Science, King Saud University, Riyadh, Saudi Arabia
P.O Box 10219, Riyadh 11433
Ethics committee country [1] 301525 0
Saudi Arabia
Date submitted for ethics approval [1] 301525 0
09/02/2016
Approval date [1] 301525 0
17/03/2016
Ethics approval number [1] 301525 0
CAMS89-36-37

Summary
Brief summary
Smoking is associated with a number of systemic diseases including respiratory disorders. Smoking accelerates pulmonary function decline and causes structural and functional changes in the musculoskeletal system, including reduced the diaphragm strength. The effect of manual therapy on improving the diaphragm strength is still not well studied. To investigate the immediate effect of manual therapy on diaphragm muscle strength in asymptomatic healthy smokers.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 87286 0
Mr Thamer Al-Shammary
Address 87286 0
King Abdul-Aziz Medical City in National Guard, Riyadh
Rehabilitation department
P.O.Box 22490RIyadh 11426
Country 87286 0
Saudi Arabia
Phone 87286 0
00966509914997
Fax 87286 0
Email 87286 0
shammartT@NGHA.med.sa
Contact person for public queries
Name 87287 0
A/Prof Mohammed Taher Ahmed Omar
Address 87287 0
Director of Nursing College Research Center
College of Applied Medical Sciences
King Saud University, Riyadh, Saudi Arabia
P.O Box 10219, Riyadh 11433
Country 87287 0
Saudi Arabia
Phone 87287 0
00966542115404
Fax 87287 0
Email 87287 0
momarar@ksu.edu.sa
Contact person for scientific queries
Name 87288 0
A/Prof Ali Albarrati,
Address 87288 0
Director of Nursing College Research Center
College of Applied Medical Sciences
King Saud University, Riyadh, Saudi Arabia
P.O Box 10219, Riyadh 11433
Country 87288 0
Saudi Arabia
Phone 87288 0
00966553215665
Fax 87288 0
Email 87288 0
albarrati@ksu.edu.sa

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary