Diaphragmatic Breathing Program In Older People

NCT ID: NCT03782779

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2019-03-10

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Breathing program and regular exercise

Diaphragmatic Breathing Program plus regular upper and lower limb exercises

Group Type: EXPERIMENTAL

Breathing program and regular exercise

Intervention Type: OTHER

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 Exercise

Regular upper and lower limb exercises

Group Type: ACTIVE_COMPARATOR

Regular Exercise

Intervention Type: OTHER

Regular upper and lower limbs exercises supervised by a physical therapist

Interventions

Breathing program and regular exercise

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.

Intervention Type: OTHER

Regular Exercise

Regular upper and lower limbs exercises supervised by a physical therapist

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Anna Arnal

PhD, Profesora Ayudante

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Arnal-Gómez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

University of Valencia

Valencia, , Spain

Countries

Spain

Other Identifiers

ID001

Identifier Type: -

Identifier Source: org_study_id