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BreathingNCT04469972

Effect of Breathing Exercise on Certain Physiological Parameters, Sleep Quality and Vitality in Elderly

A study testing Breathing Exercises in people with Breathing and Sleep Disorder, run by Aysun Erdal at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Breathing, Sleep Disorder
What is being tested?
Breathing Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Jan 2019to 5 Jun 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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.
  • Exclusion criteria. Physical / mental disability or limitation and disease that will prevent them from participating in breathing exercise (previous ear, brain, spinal cord surgery, acute retinal hemorrhage vertebral fracture and diaphragmatic rupture, hiatus or abdominal hernia, acute myocardial infarction, unstable angina pectoris, severe coronary artery disease, congestive heart failure, severe heart valve disease, acute myocarditis, acute and unstable musculoskeletal injuries, uncontrollable systemic hypertension, severe dementia and behavioral disorders)
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University

    Ankara, Yenimahalle, 06560

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Study design The study was conducted in a pre-test- post-test, randomised controlled (parallel) and experimental design.

Study population and sample The sample size was determined based on the variable under study (i.e. lung function) using the GPower 3.1.9.4 program. The pretest and post-test "FVC (L)" variable values obtained by Jun et al.18 were taken into account in the effect size calculations, being 3.26 and 3.46, with standard deviations of 0.33 and 0.61, respectively. The calculations identified a sample size that provides α = 0.05, and the power of the test (1-β) = 0.80 indicated a sample size of 26 subjects in each group. Considering the potential for losses over the course of such studies,12,15 20% of the minimum sample size (11 individuals) was added to the study so as not to reduce the statistical power of the study. It was planned in the study to include 32 elderly participants in the intervention group and 31 in the control group.The study was completed with 26 individuals in the intervention group and 25 individuals in the control group.

Sampling After the study protocol was approved by the Institutional Ethics Committee of Gazi University and the Ministry of Family and Social Policies, a nursing home selected previously according to the number of elderly people in residence was selected for the study and approached. Of the 294 elderly residents of the nursing home, 158 were excluded for not satisfying the inclusion criteria, while 60 were unwilling to take part. Consequently, 63 elderly people were entered into the study and were randomly assigned to the intervention or control groups. While assessing the residents in terms of the inclusion criteria in the study, their health status was obtained from the health unit files of the nursing home, and the Mini Mental test was applied by the researcher.

Randomisation Age and gender are significant factors affecting lung and cardiac function, and so a stratified randomization was performed to ensure the similarity of the intervention and control groups. The study participants were stratified by age (65-74 years, and ≥75 years) and gender (female/male) by the researcher, and were then assigned to the intervention and control groups using a simple randomization application within the computer-based SPSS program, with each stratum group divided equally. In this way, a balanced distribution of the groups was achieved without being affected by age and gender. Neither the study participants nor the breathing exercise trainers were blinded in the study, although the respiratory function tests were evaluated by an independent physiotherapist. The participants were called in alphabetical name order, and the measurements were made by an independent physiotherapist. The statistical analyses and reporting were performed by an independent statistician. The data were sent to the statistician with the groups coded as "Group 1" and "Group 2", without distinguishing between the intervention and control groups.

Implementation steps Pre-test: The pre-test measurements were performed by the researcher and a physiotherapy specialist in the physical therapy unit of the nursing home. The participants in both groups were called up for pretest evaluation in alphabetical name order. To begin with, the PSQI and SVS were applied by the researcher, after which the height and body weight of the participant were measured and recorded, along with their age. All these measurements take around 15 minutes. In this way, the elderly were rested and prevented from imbibing anything that could affect lung and heart function, such as cigarettes, tea or coffee, before measurement. The cardiological findings were then evaluated by the researcher. A manual sphygmomanometer and a pulse oximeter were used to assess cardiac function (blood pressure, heart rate, oxygen saturation). Prior to the oxygen saturation measurement, any blue, black, green, brown or red nail polish was removed, along with any artificial nails. Finally, pulmonary function was assessed, for which dentures were removed. The pulmonary function test procedure had been explained and shown previously by the physiotherapist to the elderly participant, and a spirometer was used for the pulmonary function (FVC, FEV1, FEV1/FVC ratio and percentages) measurement. The results were all delivered to the researcher by the authorized representative of the spirometer manufacturer in pdf format within 15 days. All other data were recorded by the researcher after measurement.

Implementation in the intervention group: A review of literature was made prior to the determination of the breathing exercise protocol to be applied to the elderly participants in the intervention group. In Jun et al., elderly smokers were given breathing exercises three times a week.18 In the study conducted by El Kader, a breathing exercise program was developed for the elderly participants involving activities three times a week for 20 minutes for a period of three months.21 Jansang et al. devised a three-month breathing exercise program for the elderly comprising a diaphragmatic breathing exercise and a pursed lip breathing exercise.12 The breathing exercises in the present study were planned taking into account the methods and recommendations made in the above and similar studies. The intervention group was 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 (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. The exercises were performed in the group activity hall of the physical therapy unit, which was determined as the most suitable area for the participants and for the exercise application, based on a joint decision of the nursing home management and the researcher. No special clothing or equipment was identified for the breathing exercise. The wind rose to be used during the exercise was provided by the researcher. All of the breathing exercises were taught to the participants on the first day of implementation, and were demonstrated again by the researcher prior to exercising throughout the implementation phase. The participants were informed about the possible symptoms that could occur during the breathing exercise, such as dizziness, and they were told to take a short break in such cases, and to wait until the dizziness was over before continuing. If the elderly person could not participate in the exercise session for any reason, the missing exercise time was compensated for the week and day, determined jointly by the elderly individual and the researcher. The breathing exercise program was as follows:

  1. Taking the appropriate position for the exercise, as demonstrated by the practitioner (5 minutes) II. Pursed-lip breathing exercise (using a windmill toy) (10 minutes) III. Take a break for 1 minute IV. Diaphragmatic breathing exercise (10 minutes) V. Take a break for 1 minute VI. Coughing exercise (10 minutes)

Implementation in the control group: None of the participants in the control group were subjected to breathing exercises, and continued their daily lives as normal.

Post-test: On the day following the breathing exercises, the PSQI, SVS and physiological parameters were applied following the same steps as in the pre-test implementation, and conducted by the same physiotherapist and researcher in the physical therapy unit. All data were recorded by the researcher in the same manner.

Data assessment The study data were evaluated using the SPSS (Statistical Package for Social Sciences) 16.0 software package. The normal distribution of the quantitative data was assessed with a Kolmogorov-Smirnov test. Numbers, percentages, means, and standard deviation and t-test values were used for the analysis of the dependent groups, and a paired samples t-test, and two-way analysis of variance was used for repeated measures. The level of significance was accepted as p<0.05. The effect size was determined based on Cohen's d value, and a partial eta square (pη2) was used as the effect size when assessing the two-way analysis of variance.

Being tested
Breathing Exercises
Keywords
Elderly, Breath exercise, Physiological changes
Medical subject headings
Respiratory Aspiration, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breathing ExercisesOther

    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)

Study groups in NCT04469972
Study groupRoleWhat they receive
Implementation in the intervention groupExperimentalThis 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.
Receives: Other: Breathing Exercises
Implementation in the control groupNo interventionNone of the elderly in the control group were subjected to breathing exercises. They continued their daily lives as normal.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

Secondary outcomes (6)
  1. Systolic blood pressure

    Systolic blood pressure was evaluated using a manual sphygmomanometer. Measurement results before and after the intervention are recorded by the researcher.

    Measured: 12 weeks

  2. Diastolic blood pressure

    Diastolic blood pressure was evaluated using a manual sphygmomanometer. Measurement results before and after the intervention are recorded by the researcher.

    Measured: 12 weeks

  3. Heart rate

    Heart rate was evaluated using a pulse oximeter, Measurement results before and after the intervention are recorded by the researcher.

    Measured: 12 weeks

  4. Oxygen saturation

    Oxygen saturation was was evaluated using a pulse oximeter, Measurement results before and after the intervention are recorded by the researcher.

    Measured: 12 weeks

  5. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI contains 18 self-rated questions and measures the quality of sleep over the last 4 weeks. The total score ranges from 0 to 21. An overall score higher than 5 indicates poor quality of sleep. The Cronbach α internal consistency coefficient of the scale is 0.80.

    Measured: 12 weeks

  6. Subjective Vitality Scale (SVS)

    The SVS is a 7-point Likert-type instrument with 7 self-rated items. The total score of the scale ranges from 7 to 49. A higher score indicates a higher level of subjective vitality. The Cronbach α internal consistency coefficient of the scale is 0.87.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start21 Jan 2019
  3. Primary completion9 May 2019
  4. Study completion5 Jun 2019

Resources

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
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04469972
Sponsor's protocol ID
not have
Status last verified
Mar 2021
First submitted
2 Jul 2020
Last updated
22 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study method can be explained. Results will be shared after the study is published

Publications

  • 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.

    PubMed 29927211

Questions about this trial

What is this clinical trial studying?

A study testing Breathing Exercises in people with Breathing and Sleep Disorder, run by Aysun Erdal at 1 site in Turkey (Türkiye).

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 7 inclusion and 0 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 22 Mar 2021. 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 Turkey (Türkiye). 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?

FVC (Forced vital capacity ),%FVC (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04469972, which also lists 1 linked publication.

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 22 Mar 2021.

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