Chronic Obstructive Pulmonary DiseaseNCT05781867
Selective Manual Therapy Techniques in Chronic Obstructive Pulmonary Disease
A study testing Manual therapy and conventional physical therapy treatment in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Our study aiming for determining the combined effect of selective manual therapy techniques in chronic obstructive pulmonary disease patients Read more about this study
- Who is it for?
- Ages 50 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Manual therapy and conventional physical therapy treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients must diagnosed mild to moderate chronic obstructive pulmonary disease
- All patients should have foreward head and kyphosis
Who cannot join
- History of osteoporosis.
- Acute exacerbation.
- Presence of active hemoptysis
- Presence of malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Selective Manual Therapy Techniques in Chronic Obstructive Pulmonary Disease
Our study aiming for determining the combined effect of selective manual therapy techniques in chronic obstructive pulmonary disease patients
Read the detailed description
I will apply selective manual therapy techniques in form of mobilization techniques ,myofascial release techniques combined with traditional treatment to determine thier effect in chronic obstructive pulmonary disease patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Manual therapy and conventional physical therapy treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy and conventional physical therapy treatmentOther
manual therapy (chest mobilization, diaphragmatic myofascial release, myofascial release for pectoralis minor, pectoralis major, scaleni ),pursed lip breathing, diaphragmatic breathing and active range of motion exercises of upper limbs
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | 26patients will be included in this group and will receive conventional physiotherapy in form of pursed lip breathing, diaphragmatic breathing exercise and Active Range of Motion of both upper extremities Receives: Other: Manual therapy and conventional physical therapy treatment |
| manual therapy | Experimental | 26patients will be included in this group and will receive manual therapy (chest mobilization, diaphragmatic myofascial release, myofascial release for pectoralis minor and major, scaleni ) and conventional physiotherapy Receives: Other: Manual therapy and conventional physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest expansion
caliper will be used to assess chest expansion into centimeter
Measured: pre-intervention and after 8 weeks of intervention
(the forced vital capacity (FVC), forced expiratory volume at first second (FEV1) and FEV1/FVC will be recorded. )
spirometry used to measure
Measured: pre-intervention
cranio-vertebral angle and kyphotic angle in degrees
kinovea software will be used to assess in degrees
Measured: pre-intervention
functional capacity.
Six minute walk test will be used to assess functional capacity(meter/minutes)
Measured: pre-intervention
dyspnea score
Modified Medical Research Council dyspnea scale (mMRC dyspnea scale) will be used to assess dyspnea
Measured: pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start20 Mar 2023
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira saad mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781867
- Sponsor's protocol ID
- manual therapy in COPD
- Status last verified
- Apr 2024
- First submitted
- 21 Jan 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: waiting to know the results of the intervention
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selective Manual Therapy Techniques in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05781867
- Acronym / sponsor ID
- manual therapy in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study aiming for determining the combined effect of selective manual therapy techniques in chronic obstructive pulmonary disease patients
Detailed description
I will apply selective manual therapy techniques in form of mobilization techniques ,myofascial release techniques combined with traditional treatment to determine thier effect in chronic obstructive pulmonary disease patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: Manual therapy and conventional physical therapy treatment26patients will be included in this group and will receive conventional physiotherapy in form of pursed lip breathing, diaphragmatic breathing exercise and Active Range of Motion of both upper extremities |
| manual therapy | Experimental | Other: Manual therapy and conventional physical therapy treatment26patients will be included in this group and will receive manual therapy (chest mobilization, diaphragmatic myofascial release, myofascial release for pectoralis minor and major, scaleni ) and conventional physiotherapy |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients must diagnosed mild to moderate chronic obstructive pulmonary disease
- All patients should have foreward head and kyphosis
Key exclusion criteria (4 listed)
- History of osteoporosis.
- Acute exacerbation.
- Presence of active hemoptysis
- Presence of malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy and conventional physical therapy treatmentmanual therapy (chest mobilization, diaphragmatic myofascial release, myofascial release for pectoralis minor, pectoralis major, scaleni ),pursed lip breathing, diaphragmatic breathing and active range of motion exercises of upper limbs | Other | control, manual therapy |
Primary outcome
chest expansion
Time frame: pre-intervention and after 8 weeks of intervention
caliper will be used to assess chest expansion into centimeter
(the forced vital capacity (FVC), forced expiratory volume at first second (FEV1) and FEV1/FVC will be recorded. )
Time frame: pre-intervention
spirometry used to measure
cranio-vertebral angle and kyphotic angle in degrees
Time frame: pre-intervention
kinovea software will be used to assess in degrees
functional capacity.
Time frame: pre-intervention
Six minute walk test will be used to assess functional capacity(meter/minutes)
dyspnea score
Time frame: pre-intervention
Modified Medical Research Council dyspnea scale (mMRC dyspnea scale) will be used to assess dyspnea
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Undecided. waiting to know the results of the intervention
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and conventional physical therapy treatment in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chest expansion (time frame: pre-intervention and after 8 weeks of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.