- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03827356
"Inspiratory Muscle Training in Older Women"
"Comparison Between Two Programs of Inspiratory Muscle Training, Low Resistance vs High Resistance, in Institutionalized Older Women"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants:
Institutionalized women will be recruited to participate in an 8-week randomized trial.
All patients will be asked to carry out the 5-day weekly program, and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session. All participants signed an informed consent form.
The patients will be assigned to the two groups randomly. The main researcher doesn´t meet any of the participants until the initial assessment will be carried out.
Evaluation:
The participants are evaluated at the beginning and end of the intervention period.
The evaluation of MIP and MEP is performed using a pressure transducer, Elka 15, which obtains each measurement in millibar and converts it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O .), following the rules of the American thoracic society/European respiratory society (ATS / ERS). The procedure will be repeated until 3 values were obtained with a difference of less than 5%, and the highest value will be used for the analysis. The MIP of the intervention group will be assessed every 2 weeks to set the IMT workload.
Lung volumes are assessed using a spirometer (model: datospir touch) with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules will be followed [19], and the highest value of three correct measurements will be chosen. Data is collected for the following parameters: maximum voluntary ventilation (MVV), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF), mean expiratory flow (FEF25-75), vital capacity (VC), tidal volume (TV) and forced vital capacity (FVC).
Dyspnea will be measured using the modified Borg scale [20]. Functional capacity will be measured with 6 minute walk test. All evaluations will be done in the corresponding center, during the same time slot and by the same examiner for both groups.
Intervention:
"High-intensity group". The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).
The intensity of the device will be 40% of MIP. The protocol includes 15 cycles lasting 1 minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1 minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
"Low-intensity group".The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).
The intensity of the device will be 20% of MIP. The protocol includes 15 cycles lasting 1 minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1 minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Salamanca, Spain, 37006
- Carlos Martin Sanchez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Women
- Older 65 years
- Barthel > 60
- Understand the objectives and be able to complete questionaires
Exclusion criteria:
- Respiratory pathology during the 4 weeks prior the start of the study
- Any complication that may impeded the performance of the evaluation tests or breathing techniques
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: "High intensity group"
Intervention is administrated with an inspiratory muscle trainer (IMT).
High intensity group: 15 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles.
|
The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).
|
Active Comparator: "Low intensity group"
Intervention is administrated with an inspiratory muscle trainer (IMT).
Low intensity group: 15 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles.
|
The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal inspiratory pressure (MIP)
Time Frame: 2 minutes
|
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS).
The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis.
The MIP of the intervention group was assessed every 2 weeks to set the IMT workload.
|
2 minutes
|
Maximal expiratory pressure (MEP)
Time Frame: 2 minutes
|
The evaluation is performed using a pressure transducer, Elka 15.
It is evaluated at the beginning and at the end of the interventional phase.
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced expiratory volume in the first second (FEV1)
Time Frame: 1 minute
|
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l.
The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen.
Measure: L
|
1 minute
|
Vital capacity (VC)
Time Frame: 1 minute
|
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l.
The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen.
Measure: L
|
1 minute
|
Tidal volume (VT)
Time Frame: 1 minute
|
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l.
The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen.
Measure: L
|
1 minute
|
Forced vital capacity (FVC)
Time Frame: 1 minute
|
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l.
The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen.
Measure: L
|
1 minute
|
Maximum voluntary ventilation (MVV)
Time Frame: 1 minute
|
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l.
The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen.
Measure: Liter (L)/Minute (min)
|
1 minute
|
Peak expiratory flow (PEF)
Time Frame: 1 minute
|
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l.
The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen.
Measure: L/second (seg)
|
1 minute
|
Mean expiratory flow (FEF25-75)
Time Frame: 1 minute
|
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l.
The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen.
Measure L/seg
|
1 minute
|
Functional capacity
Time Frame: 6 minutes
|
The 6 minutes walk test provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
|
6 minutes
|
Dyspnea
Time Frame: 1 minute
|
Modified Borg scale.
It is a numerical scale graduated between 0 and 10, where 0 is the minimum or without dyspnea and 10 is the maximum or extreme dyspnea.
|
1 minute
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27112018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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