Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04469972 |
| Other study ID # |
not have |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 21, 2019 |
| Est. completion date |
June 5, 2019 |
Study information
| Verified date |
March 2021 |
| Source |
Gazi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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:
I. 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.
