Clinical trial NCT03782779: Diaphragmatic Breathing Program In Older People
Official title: Respiratory Physical Therapy Based on Diaphragmatic Breathing Program In Institutionalized Older People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Respiratory physical therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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) .

Exclusion Criteria:

* subjects with respiratory diseases
* Subjects with musculoskeletal injuries that prevented the performance of the exercise protocol were excluded.

Primary outcomes:
measure: Forced spirometry
timeFrame: 8 weeks
measure: Pulse oxymetry
timeFrame: 8 weeks
Secondary outcomes:
measure: Minimental State Examination Folstein
timeFrame: first week
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Anna Arnal-Gómez, PhD
role: PRINCIPAL_INVESTIGATOR
References: