Respiratory DiseaseNCT01735474
Results of Manual Therapy on Pulmonary Parameters
A study testing Manual technique in people with Respiratory Disease, run by Universidad de Granada at 1 site in Spain.
Trial summary
The main objective of this study is to evaluate the effectiveness of different manual techniques included traditionally on respiratory physical therapy Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Manual technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Apr 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects with respiratory conditions
- Must be able to do spirometry
Who cannot join
- subjects with acute processes in their pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Therapy Results on Pulmonary Function and Musculoskeletal Movement
The main objective of this study is to evaluate the effectiveness of different manual techniques included traditionally on respiratory physical therapy
Read the detailed description
Randomized controlled trial. Participants are classified in two groups and they are assessed using pulmonary functions parameters and thoracic and spinal movements.
There are two interventions: placebo and a manual technique. Participants will be assessed again at the end of the study.
- Conditions
- Respiratory Disease
- Being tested
- Manual technique, Placebo
- Keywords
- manual therapy, respiratory disease, thoracic movement
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual techniqueOther
Also called Manual therapy.
A manual technique is employed in the intervention group based on passive movement and stretching of the respiratory system.
The manual technique includes:
stretching of diaphragm. Mobilization. Potentiation of the respiratory muscles.
PlaceboOther
Also called No intervention
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 30 people are recruited in order to the inclusion criteria for the study. Placebo controlled. Receives: Other: Placebo |
| Manual technique | Active comparator | 30 people are recruited in order to the inclusion criteria for the study. Experimental group. Receives: Other: Manual technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
spirometry parameters
Change from baseline to postintervention in spirometry parameters (Vital capacity, Forced expiratory volume in the first second (FEV1), Tidal volume)using a spirometer as recommended by the American Thoracic Society.
Measured: Baseline, 6 months
Secondary outcomes (4)
thoracic movement
Changes from baseline to postintervention in thoracic movement, measured by tape measure in 3 thoracic levels.
Measured: at baseline, 6 months
Changes on Functionality scores
Functional status questionnaire used before and after intervention to measure functionality scores change.
Measured: baseline, 6 months
Changes on cardiorespiratory capacity
Changes on cardiorespiratory capacity measured by 6MWT (6 minutes walking test)at baseline and post intervention.
Measured: baseline, 6 months
spinal movement
Changes from baseline to postintervention in spinal movement, measured by Range of motion with goniometer.
Measured: at baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2017 (estimated)
- Study completionApr 2017 (estimated)
Why it stopped: Sample size was not completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Carmen M Valenza, PH MD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735474
- Sponsor's protocol ID
- DF0035UG
- Status last verified
- Nov 2016
- First submitted
- 5 Nov 2012
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy Results on Pulmonary Function and Musculoskeletal Movement
- ClinicalTrials.gov ID
- NCT01735474
- Acronym / sponsor ID
- DF0035UG
- Conditions
- Respiratory Disease
- Keywords
- manual therapy, respiratory disease, thoracic movement
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sample size was not completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 28 Nov 2012 (estimated)
- 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.
The main objective of this study is to evaluate the effectiveness of different manual techniques included traditionally on respiratory physical therapy
Detailed description
Randomized controlled trial. Participants are classified in two groups and they are assessed using pulmonary functions parameters and thoracic and spinal movements.
There are two interventions: placebo and a manual technique. Participants will be assessed again at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo30 people are recruited in order to the inclusion criteria for the study. Placebo controlled. |
| Manual technique | Active comparator | Other: Manual technique30 people are recruited in order to the inclusion criteria for the study. Experimental group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects with respiratory conditions
- Must be able to do spirometry
Key exclusion criteria (1 listed)
- subjects with acute processes in their pathologies
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 techniqueAlso: Manual therapy.A manual technique is employed in the intervention group based on passive movement and stretching of the respiratory system. The manual technique includes: stretching of diaphragm. Mobilization. Potentiation of the respiratory muscles. | Other | Manual technique |
| PlaceboAlso: No interventionUsual care | Other | Placebo |
Primary outcome
spirometry parameters
Time frame: Baseline, 6 months
Change from baseline to postintervention in spirometry parameters (Vital capacity, Forced expiratory volume in the first second (FEV1), Tidal volume)using a spirometer as recommended by the American Thoracic Society.
4 secondary outcomes
thoracic movement
Time frame: at baseline, 6 months
Changes on Functionality scores
Time frame: baseline, 6 months
Changes on cardiorespiratory capacity
Time frame: baseline, 6 months
spinal movement
Time frame: at baseline, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Carmen M Valenza, PH MD principal investigator
Universidad de Granada
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 technique in people with Respiratory Disease, run by Universidad de Granada at 1 site in Spain.
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 1 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: paused, as of the sponsor's last update on 3 Nov 2016. 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 Spain. 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?
Results are not available in the source record.
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?
spirometry parameters (time frame: Baseline, 6 months). 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 3 Nov 2016.