AgingBP-OPNCT03782779
Diaphragmatic Breathing Program In Older People
A study testing Breathing program and regular exercise and Regular Exercise in people with Aging, run by University of Valencia at 1 site in Spain.
Trial summary
In the present study a program of respiratory physical therapy based on diaphragmatic breathing is applied in institutionalized old people, evaluating lung function parameters (FVC, FEV1, FEV1/FVC) and oxygen saturation. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Breathing program and regular exercise and Regular Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jan 2019to 10 Mar 2019
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- institutionalized subjects older than or equal to 60 years
- without respiratory pathology diagnosed
- with adequate cognitive status to follow the protocol of respiratory exercises (MEC>30) .
Who cannot join
- subjects with respiratory diseases
- Subjects with musculoskeletal injuries that prevented the performance of the exercise protocol were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Physical Therapy Based on Diaphragmatic Breathing Program In Institutionalized Older People
In the present study a program of respiratory physical therapy based on diaphragmatic breathing is applied in institutionalized old people, evaluating lung function parameters (FVC, FEV1, FEV1/FVC) and oxygen saturation.
The hypothesis is that a diaphragmatic breathing program applied in elderly people can improve the respiratory system's function and consequently improve their daily life. This program will include learning and performing a diaphragmatic-abdominal breathing, and incorporating the new breathing pattern to a upper and lower limbs maintenance exercises as well as to daily life activities.
Methods: randomized and controlled clinical study of respiratory parameters of institutionalized old people. The subjects will be divided into 2 groups: 1) diaphragmatic breathing program and upper and lower limbs maintenance exercises 2) control group which do upper and lower limbs maintenance exercises. There will be 3 treatment sessions during 8 weeks, with evaluations before the study and after 8 weeks, which include: lung function parameters (forced vital capacity, forced expiratory volume in one second, Tiffeneau Index) and pulseoximeter (which includes oxygen saturation and cardiac frequency).
Read the detailed description
Introduction.The aging of the respiratory system includes physiological changes of the lung as well as the osteoarticular and muscular tissues. Therefore, the European and North American Respiratory Societies highlight in their recommendations the importance of prevention of respiratory diseases. They also insist on the need to maintain the integrity of the anatomical elements that participate in the thoraco-abdominal movements and on preventive treatments in those at risk before the symptoms appear.
Objective. The main objective of this study is to apply a program of supervised breathing program in old people with no respiratory health issues and evaluate the effects on respiratory variables such as forced vital capacity (FVC) forced expiratory volume in one second (FEV1) Tiffeneau Index (FEV1/FVC) and oxygen satutarion (SO2).
Material and Methods Sample: over 60 year old subjects, institutionalized and with no respiratory condition.
Study design. Randomized clinical trial with 2 groups: Group 1. diaphragmatic breathing program and upper and lower limbs maintenance exercises ; Group 2. control group which only do upper and lower limbs maintenance exercises.
Evaluations. Clinical interview with anthropometric data and health characteristics.
There will be 2 evaluations: at the beginning of the study and at the end of the supervised program (at 8 weeks).
In addition, it includes the following evaluation instruments:
- Mini-mental State Examination (MMSE)
- Spirometry: obtaining FVC, FEV1, FEV1/FVC.
- Pulse oxymetry: it measure the SaO2 and cardiac frequency.
- Conditions
- Aging
- Being tested
- Breathing program and regular exercise, Regular Exercise
- Keywords
- Respiratory physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing program and regular exerciseOther
This program will be supervised by a physical therapist and will include learning and performing a diaphragmatic-abdominal breathing, and incorporating the new breathing pattern to a upper and lower limbs regular exercises as well as to daily life activities.
Regular ExerciseOther
Regular upper and lower limbs exercises supervised by a physical therapist
| Study group | Role | What they receive |
|---|---|---|
| Breathing program and regular exercise | Experimental | Diaphragmatic Breathing Program plus regular upper and lower limb exercises Receives: Other: Breathing program and regular exercise |
| Regular Exercise | Active comparator | Regular upper and lower limb exercises Receives: Other: Regular Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced spirometry
Assessed using a COSMED PONY FX spirometer with mouthpiece and filters (1 cardboard mouthpiece and a bacteriological filter per patient). The test was performed with the person sitting, without crossing the legs and shoulders relaxed. Anthropometric data were entered into the equipment, nose was covered with a nose clio and the patient was then asked to perform three forced inhalations and exhalations.
Measured: 8 weeks
Pulse oxymetry
To assess oxygen saturation, a SmartOx pulse oximeter (WEINMANN Medical Technology) is used. The subject remains seated, the pulse oximeter clamp placed on a finger of one of the hands, waiting for the SaO2 and CF value to stabilize and register the value.
Measured: 8 weeks
Secondary outcomes (1)
Minimental State Examination Folstein
Mini-Cognitive Lobo est (MEC). To assess the cognitive status before inclusion in the study, the spanish version of Folstein's Minimental State Examination is used. Adapted and validated by Lobo in Spain in 1979. It is a brief cognitive test that consists of the evaluation of the most important cognitive areas (orientation, concentration, calculation, memory, language and construction) with a global maximum score of 35 (30-35 = normal, 24-29 = borderline, <24 in people over 65). The MEC has widely shown its reliability, validity and discriminative power, with a specificity of 75.1% and a sensitivity of 89.8%.
Measured: first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start3 Jan 2019
- Primary completion7 Jan 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Arnal Gómez, University of Valencia
- Investigators
- Anna Arnal-Gómez, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782779
- Sponsor's protocol ID
- PHYSIORESP_OLDERADULTS
- Acronym
- BP-OP
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2018
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Physical Therapy Based on Diaphragmatic Breathing Program In Institutionalized Older People
- ClinicalTrials.gov ID
- NCT03782779
- Acronym / sponsor ID
- BP-OP / PHYSIORESP_OLDERADULTS
- Conditions
- Aging
- Keywords
- Respiratory physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 20 Dec 2018 (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.
In the present study a program of respiratory physical therapy based on diaphragmatic breathing is applied in institutionalized old people, evaluating lung function parameters (FVC, FEV1, FEV1/FVC) and oxygen saturation.
The hypothesis is that a diaphragmatic breathing program applied in elderly people can improve the respiratory system's function and consequently improve their daily life. This program will include learning and performing a diaphragmatic-abdominal breathing, and incorporating the new breathing pattern to a upper and lower limbs maintenance exercises as well as to daily life activities.
Methods: randomized and controlled clinical study of respiratory parameters of institutionalized old people. The subjects will be divided into 2 groups: 1) diaphragmatic breathing program and upper and lower limbs maintenance exercises 2) control group which do upper and lower limbs maintenance exercises. There will be 3 treatment sessions during 8 weeks, with evaluations before the study and after 8 weeks, which include: lung function parameters (forced vital capacity, forced expiratory volume in one second, Tiffeneau Index) and pulseoximeter (which includes oxygen saturation and cardiac frequency).
Detailed description
Introduction.The aging of the respiratory system includes physiological changes of the lung as well as the osteoarticular and muscular tissues. Therefore, the European and North American Respiratory Societies highlight in their recommendations the importance of prevention of respiratory diseases. They also insist on the need to maintain the integrity of the anatomical elements that participate in the thoraco-abdominal movements and on preventive treatments in those at risk before the symptoms appear.
Objective. The main objective of this study is to apply a program of supervised breathing program in old people with no respiratory health issues and evaluate the effects on respiratory variables such as forced vital capacity (FVC) forced expiratory volume in one second (FEV1) Tiffeneau Index (FEV1/FVC) and oxygen satutarion (SO2).
Material and Methods Sample: over 60 year old subjects, institutionalized and with no respiratory condition.
Study design. Randomized clinical trial with 2 groups: Group 1. diaphragmatic breathing program and upper and lower limbs maintenance exercises ; Group 2. control group which only do upper and lower limbs maintenance exercises.
Evaluations. Clinical interview with anthropometric data and health characteristics.
There will be 2 evaluations: at the beginning of the study and at the end of the supervised program (at 8 weeks).
In addition, it includes the following evaluation instruments:
- Mini-mental State Examination (MMSE)
- Spirometry: obtaining FVC, FEV1, FEV1/FVC.
- Pulse oxymetry: it measure the SaO2 and cardiac frequency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing program and regular exercise | Experimental | Other: Breathing program and regular exerciseDiaphragmatic Breathing Program plus regular upper and lower limb exercises |
| Regular Exercise | Active comparator | Other: Regular ExerciseRegular upper and lower limb exercises |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- institutionalized subjects older than or equal to 60 years
- without respiratory pathology diagnosed
- with adequate cognitive status to follow the protocol of respiratory exercises (MEC>30) .
Key exclusion criteria (2 listed)
- subjects with respiratory diseases
- Subjects with musculoskeletal injuries that prevented the performance of the exercise protocol were excluded.
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 |
|---|---|---|
| Breathing program and regular exerciseThis program will be supervised by a physical therapist and will include learning and performing a diaphragmatic-abdominal breathing, and incorporating the new breathing pattern to a upper and lower limbs regular exercises as well as to daily life activities. | Other | Breathing program and regular exercise |
| Regular ExerciseRegular upper and lower limbs exercises supervised by a physical therapist | Other | Regular Exercise |
Primary outcome
Forced spirometry
Time frame: 8 weeks
Assessed using a COSMED PONY FX spirometer with mouthpiece and filters (1 cardboard mouthpiece and a bacteriological filter per patient). The test was performed with the person sitting, without crossing the legs and shoulders relaxed. Anthropometric data were entered into the equipment, nose was covered with a nose clio and the patient was then asked to perform three forced inhalations and exhalations.
Pulse oxymetry
Time frame: 8 weeks
To assess oxygen saturation, a SmartOx pulse oximeter (WEINMANN Medical Technology) is used. The subject remains seated, the pulse oximeter clamp placed on a finger of one of the hands, waiting for the SaO2 and CF value to stabilize and register the value.
1 secondary outcome
Minimental State Examination Folstein
Time frame: first week
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 16 Oct 2026.
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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.
Anna Arnal-Gómez, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing program and regular exercise and Regular Exercise in people with Aging, run by University of Valencia 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 3 inclusion and 2 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 16 Oct 2026. 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?
Forced spirometry (time frame: 8 weeks). The study lists 2 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 16 Oct 2026.