Manual TherapiesNCT02514161
Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers
A study testing Inspiratory Muscle training in people with Manual Therapies and Respiratory Muscle Training, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The aim of this study is to assess if an intervention of manual therapy and motor control exercises combined with an inspiratory muscle training program is more effective than an inspiratory muscle training program alone in increasing the maximum inspiratory pressure in moderate smokers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual Therapies, Respiratory Muscle Training, Exercise Therapy
- What is being tested?
- Inspiratory Muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Nov 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged between 18 and 60 years and a current smoking rate ≥ 5 points.
Who cannot join
- Were excluded participants who presented diagnosis of cardiorespiratory disease, systemic or metabolic disease such as rheumatoid arthritis or cancer, history of thoracic surgery, vertebral fracture, spinal structured musculoskeletal disorders and thoracic region and contraindication to the treatment techniques used (osteoporosis).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Superior de Estudios Universitarios La Salle
Madrid, Madrid, 28023
About this study
Official title: Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Moderate Smokers
The aim of this study is to assess if an intervention of manual therapy and motor control exercises combined with an inspiratory muscle training program is more effective than an inspiratory muscle training program alone in increasing the maximum inspiratory pressure in moderate smokers. In addition, the study pretends to evaluate the changes caused by the intervention regarding possible postural changes and thoracic diameter.
- Being tested
- Inspiratory Muscle training, IMT + Manual Therapy and Motor Control Exercise
- Keywords
- Smokers, Maximum Inspiratory Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle trainingOther
This protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama)
IMT + Manual Therapy and Motor Control ExerciseOther
The Inspiratory Muscle Training protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama). Manual Therapy and Motor Control Exercises will consist of joint mobilization/manipulation and exercises in the neck and thoracic regions
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training Group (IMT) | Active comparator | The IMT program consisted of supervised and domiciliary exercises.
1. - The supervised exercises was performed in the presence of physiotherapist. This consisted of 30 min 2 days for 4 weeks using the threshold device (Powerbreathe classic level 1, Gaiam Ltd; Southam, Warwickshire, UK). This program involve 5 sets of 5 repetitions with 30 seconds rest between each one. The load of the training was distributed as follow:
* First week: 30% Maximum Inspiratory Pressure (MIP)
* Second week: 40% MIP
* Third week: 50% MIP
* Fourth week: 60% MIP
2. - The domiciliary exercises consisted of Yoga Breathing Exercises (Pranayama) that combines the inspiration and expiration through one or both nostrils, and requires the activation of chest and abdomen Receives: Other: Inspiratory Muscle training |
| IMT + Manual Therapy and Motor Control Exercises | Experimental | The protocol for this group is identical to the previous group with the sole difference that is added a manual therapy (MT) and a motor control exercises (MCE). The MT protocol was performed for 15min, whereas the MCE was 10min. Below it described both protocols:
1. - MT:
* Upper cervical region mobilization in flexion
* Lower cervical postero-anterior mobilization + maintained traction
* Costovertebral joint postero-anterior mobilization
* Thoracic vertebral posteroanterior mobilization
* Thrust dorsal
2. - MCE:
* Isometric contraction of the deep neck flexors.
* Isometric contraction of the neck extensors.
* Neural self-mobilization.
* Cervical retraction with theraband.
* Sphinx.
* Scapular adduction exercises in prone.
* Scapular adduction exercises in sitting position with theraband. Receives: Other: IMT + Manual Therapy and Motor Control Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Inspiratory Pressure
The maximum inspiratory pressure (MIP) was measured with a device called Kinetic KH1 Powerbreath (HAB International Ltd., England, UK). This device applies an inspiratory load which provides a resistance. The maneuver was performed in a sitting position. Measuring a minimum of 3 times was performed, recording the highest value.
Measured: Change from Baseline in Maximum Inspiratory Pressure at 4 weeks
Secondary outcomes (3)
Head posture
The head posture was measured through the Cervical Range of Motion (CROM) device. This instrument measures physiological movements of the cervical spine and head position. It´s a reliable method of measuring, providing a range of intra-meter reliability from 0.7 to 0.9 and a range of inter-meter reliability from 0.8 to 0.87. The evaluator instructed the patient to sit in a standardized position and assume a natural position of the head and the goniometer was placed over his head to measure the head posture.
Measured: Change from Baseline in Head Posture at 4 weeks
Thoracic kyphosis
The measurement of the thoracic kyphosis was performed through flexicurve. It is a flexible rule that is molded to the back of the subject in order to replicate the shape of the spine. The flexicurve is a valid and reliable tool. The spinous processes of C7 and T12 were located, subsequently it placed on paper 10x10 to draw the curve and to obtained the index flexicurve.
Measured: Change from Baseline in Thoracic kyphosis at 4 weeks
Volumes and lung capacities
The investigators used a simple Spirometry. The Spirometry was performed according to American Thoracic Society criteria with a portable Spirometer model spirobank usb (MIR Rome, Italy). The measures assessed in this outcome were: Forced Vital Capacity (FVC), Forced Expiratory Volume at the First second (FEV1), and Peak Expiratory Flow (PEF). The maneuver was performed 3 times and recording the best one
Measured: Change from Baseline in Volumes and lung capacities at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manual TherapiesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibai López-de-Uralde-Villanueva, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514161
- Sponsor's protocol ID
- CSEU La Salle
- Status last verified
- Jul 2015
- First submitted
- 29 Jul 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Moderate Smokers
- ClinicalTrials.gov ID
- NCT02514161
- Acronym / sponsor ID
- CSEU La Salle
- Keywords
- Smokers, Maximum Inspiratory Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Aug 2015 (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 aim of this study is to assess if an intervention of manual therapy and motor control exercises combined with an inspiratory muscle training program is more effective than an inspiratory muscle training program alone in increasing the maximum inspiratory pressure in moderate smokers. In addition, the study pretends to evaluate the changes caused by the intervention regarding possible postural changes and thoracic diameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training Group (IMT) | Active comparator | Other: Inspiratory Muscle trainingThe IMT program consisted of supervised and domiciliary exercises. 1. - The supervised exercises was performed in the presence of physiotherapist. This consisted of 30 min 2 days for 4 weeks using the threshold device (Powerbreathe classic level 1, Gaiam Ltd; Southam, Warwickshire, UK). This program involve 5 sets of 5 repetitions with 30 seconds rest between each one. The load of the training was distributed as follow: * First week: 30% Maximum Inspiratory Pressure (MIP) * Second week: 40% MIP * Third week: 50% MIP * Fourth week: 60% MIP 2. - The domiciliary exercises consisted of Yoga Breathing Exercises (Pranayama) that combines the inspiration and expiration through one or both nostrils, and requires the activation of chest and abdomen |
| IMT + Manual Therapy and Motor Control Exercises | Experimental | Other: IMT + Manual Therapy and Motor Control ExerciseThe protocol for this group is identical to the previous group with the sole difference that is added a manual therapy (MT) and a motor control exercises (MCE). The MT protocol was performed for 15min, whereas the MCE was 10min. Below it described both protocols: 1. - MT: * Upper cervical region mobilization in flexion * Lower cervical postero-anterior mobilization + maintained traction * Costovertebral joint postero-anterior mobilization * Thoracic vertebral posteroanterior mobilization * Thrust dorsal 2. - MCE: * Isometric contraction of the deep neck flexors. * Isometric contraction of the neck extensors. * Neural self-mobilization. * Cervical retraction with theraband. * Sphinx. * Scapular adduction exercises in prone. * Scapular adduction exercises in sitting position with theraband. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects aged between 18 and 60 years and a current smoking rate ≥ 5 points.
Key exclusion criteria (1 listed)
- Were excluded participants who presented diagnosis of cardiorespiratory disease, systemic or metabolic disease such as rheumatoid arthritis or cancer, history of thoracic surgery, vertebral fracture, spinal structured musculoskeletal disorders and thoracic region and contraindication to the treatment techniques used (osteoporosis).
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 |
|---|---|---|
| Inspiratory Muscle trainingThis protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama) | Other | Inspiratory Muscle Training Group (IMT) |
| IMT + Manual Therapy and Motor Control ExerciseThe Inspiratory Muscle Training protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama). Manual Therapy and Motor Control Exercises will consist of joint mobilization/manipulation and exercises in the neck and thoracic regions | Other | IMT + Manual Therapy and Motor Control Exercises |
Primary outcome
Maximum Inspiratory Pressure
Time frame: Change from Baseline in Maximum Inspiratory Pressure at 4 weeks
The maximum inspiratory pressure (MIP) was measured with a device called Kinetic KH1 Powerbreath (HAB International Ltd., England, UK). This device applies an inspiratory load which provides a resistance. The maneuver was performed in a sitting position. Measuring a minimum of 3 times was performed, recording the highest value.
3 secondary outcomes
Head posture
Time frame: Change from Baseline in Head Posture at 4 weeks
Thoracic kyphosis
Time frame: Change from Baseline in Thoracic kyphosis at 4 weeks
Volumes and lung capacities
Time frame: Change from Baseline in Volumes and lung capacities at 4 weeks
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 2 Dec 2015.
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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 Inspiratory Muscle training in people with Manual Therapies and Respiratory Muscle Training, run by Universidad Autonoma de Madrid 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 1 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: finished, as of the sponsor's last update on 2 Dec 2015. 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. 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?
Maximum Inspiratory Pressure (time frame: Change from Baseline in Maximum Inspiratory Pressure at 4 weeks). 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 2 Dec 2015.