Diaphragmatic Breathing Program In Older People

NCT03782779 | Completed

• 1 other identifier: ID001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Aging

Keywords

Respiratory physical therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8 weeks

Secondary Outcomes (1)

• Minimental State Examination Folstein

  first week

Study Arms (2)

Breathing program and regular exercise

EXPERIMENTAL

Diaphragmatic Breathing Program plus regular upper and lower limb exercises

Other: Breathing program and regular exercise

Regular Exercise

ACTIVE COMPARATOR

Regular upper and lower limb exercises

Other: Regular Exercise

Interventions

Breathing program and regular exercise 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.

Breathing program and regular exercise

Regular Exercise OTHER

Regular upper and lower limbs exercises supervised by a physical therapist

Regular Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) .

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Study Officials

• Anna Arnal-Gómez, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Profesora Ayudante

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 20, 2018
• Study Start: January 3, 2019
• Primary Completion: January 7, 2019
• Study Completion: March 10, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

ES (1)