Effect of Breathing Exercise on Certain Physiological Parameters, Sleep Quality and Vitality in Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- FEV1/FVC, %FEV1/FVC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- 未提供
结局指标
主要结局
FEV1/FVC, %FEV1/FVC
时间窗: 12 weeks
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.
FVC (Forced vital capacity ),%FVC
时间窗: 12 weeks
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.
FEV1 (air volume after 1 second of forced expiration),%FEV1
时间窗: 12 weeks
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.
次要结局
- Diastolic blood pressure(12 weeks)
- Oxygen saturation(12 weeks)
- Heart rate(12 weeks)
- Systolic blood pressure(12 weeks)
- Subjective Vitality Scale (SVS)(12 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(12 weeks)
研究者
Aysun Erdal
reseach assistant
Gazi University
