NCT04469972

Brief Summary

Objective: To determine the effect of breathing exercises on certain physiological parameters, sleep quality and vitality in the elderly. Method: In this randomized controlled, experimental study, pre and post tests were applied to 26 elderly participants in the intervention group and to 25 elderly patients in the control group. The intervention group underwent breathing exercises for 30 minutes at the same time of the day, three days a week for three months (pursed-lip breathing exercise, deep breathing exercise, coughing exercise), while no such exercise was carried out by the control group. Pittsburg Sleep Quality Index, the Subjective Vitality Scale, spirometer, sphygmomanometer and pulse oximetry device measurements were used for the collection of data. The data was evaluated with an independent sample t-test, a paired-sample t-test and a two-way repeated measures ANOVA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

July 2, 2020

Last Update Submit

March 18, 2021

Conditions

Keywords

ElderlyBreath exercisePhysiological changes

Outcome Measures

Primary Outcomes (3)

  • FVC (Forced vital capacity ),%FVC

    FVC was evaluated using a spirometer. The spirometer measurement results are compared FVC values with the expected values (predicted values) pre-calculated in healthy individuals of the same age, height and gender by the software found in the spirometer device and expressed as a percentage of these values.The results are delivered to the researcher by the authorised representative of the spirometer in pdf format within 15 days.

    12 weeks

  • FEV1 (air volume after 1 second of forced expiration),%FEV1

    FEV1 was evaluated using a spirometer. The spirometer measurement results are compared FEV1 values with the expected values (predicted values) pre-calculated in healthy individuals of the same age, height and gender by the software found in the spirometer device and expressed as a percentage of these values. The results are delivered to the researcher by the authorised representative of the spirometer in pdf format within 15 days.

    12 weeks

  • FEV1/FVC, %FEV1/FVC

    FEV1/FVC was evaluated using a spirometer. The spirometer measurement results are compared FEV1/FVC with the expected values (predicted values) pre-calculated in healthy individuals of the same age, height and gender by the software found in the spirometer device and expressed as a percentage of these values.The results are delivered to the researcher by the authorised representative of the spirometer in pdf format within 15 days.

    12 weeks

Secondary Outcomes (6)

  • Systolic blood pressure

    12 weeks

  • Diastolic blood pressure

    12 weeks

  • Heart rate

    12 weeks

  • Oxygen saturation

    12 weeks

  • Pittsburgh Sleep Quality Index (PSQI)

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Implementation in the intervention group

EXPERIMENTAL

This group of elderly were subjected to a pursed-lip breathing exercise (using a windmill toy), a diaphragmatic breathing exercise and a coughing exercise three times a week (Mondays, Tuesdays and Thursdays) for 12 weeks in groups of 5-6 individuals (2 groups of 6 persons, and 4 groups of 5 persons: 6 groups in total) between 10:00 and 15:30, at the same time of the day for each group in 30-minute sessions. All breathing exercises were taught to the elderly individuals on the first day of implementation and demonstrated again prior to practice by the researcher throughout the implementation phase.

Other: Breathing Exercises

Implementation in the control group

NO INTERVENTION

None of the elderly in the control group were subjected to breathing exercises. They continued their daily lives as normal.

Interventions

Breathing exercise is defined as therapeutic intervention to create a particular form of breathing.The application of the breathing exercise program is as follows; I. Pursed Lip Breathing Exercise (Total 10 minutes) II. Diaphragmatic breathing exercise (10 minutes in total), III. Cough exercise (Total 10 minutes)

Implementation in the intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Residing individuals at a nursing home in Ankara included the study;
  • aged 65 years and older
  • had a Mini Mental Test score of ≥24,15
  • had no acute or chronic lung diseases,
  • had no physical/mental disabilities or limitations and conditions that might present any obstacle to participate in breathing exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

Related Publications (1)

  • Jansang S, Mickleborough T, Suksom D. Effects of Pursed-Lip Breathing Exercise Using Windmill Toy on Lung Function and Respiratory Muscle Strength in the Elderly. J Med Assoc Thai. 2016 Sep;99(9):1046-51.

Related Links

MeSH Terms

Conditions

Respiratory AspirationSleep Wake Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNervous System DiseasesNeurologic ManifestationsSigns and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Naile Bilgili

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
reseach assistant

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 14, 2020

Study Start

January 21, 2019

Primary Completion

May 9, 2019

Study Completion

June 5, 2019

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Study method can be explained. Results will be shared after the study is published

Locations