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临床试验/NCT05890443
NCT05890443已完成不适用

Mobile Application-Based Exercise Program Effects on Quality Of Life ın COPD; Randomized Experimental Study

T.C. ORDU ÜNİVERSİTESİ4 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
4
主要终点
Dyspnea

研究概览

简要总结

Abstract Purpose: This study aimed to determine the effect of mobile application-based exercise programs on the quality of life and dyspnea of patients with chronic obstructive pulmonary disease. This study was designed experimentally with a randomized control group.

Methods: A total of 76 COPD patients were included in the study. Individuals aged 40 and over with COPD were included in the study, while individuals with communication, mental, neurological and cognitive problems and unable to exercise were excluded from the study. Among those who met the inclusion criteria, those who had a smart-phone were assigned to the experimental group, while those who did not have a smart-phone were assigned to the control group. Self-management training was given to all individuals in both the control and experimental groups. After the training, the Saint George Respiratory Questionnaire (SGRQ) and dyspnea tests were administered to both groups. After the rehabilitation exercise program developed for the patients in the experimental group was applied, the tests were repeated for all groups.

Results: The mean age of the patients in the study was 65.5708± 9 in the control group, while the mean age of the experimental group was 67.61± 9.93. While the Borg dyspnea scale results of the experimental group were 6.45± 1.90 in the first test, the post-test measurements were 5.16± 1.65 (t = 7.66, p = 0.00). SGRQ pre-test and post-test total scores were 50.78± 16.39 and 41.99±15.04, respectively, in the experimental group (t=6.80 and p=0.08).

Conclusion: Respiratory and muscle strengthening exercises applied with the support of the mobile application, positively affected the quality of life of patients with COPD.

详细描述

Mobile Application-Based Exercise Program Effects on Quality Of Life ın COPD; Randomized Experimental Study

  1. Introduction Chronic Obstructive Pulmonary Disease (COPD), is a common progressive but treatable disease characterized by airway obstruction. Symptoms such as shortness of breath and fatigue, especially during exercise, lead to a decrease in physical activity and fitness of these patients. 1, 2 This decrease in activity causes deterioration in the health-related quality of life of the individual. The primary goal of effective COPD treatment is to reduce the patient's symptoms and future risks. Respiratory rehabilitation, a non-pharmacological treatment method, is a first-line management strategy in patients with COPD. These rehabilitation programs reduces shortness of breath, increases exercise capacity and improves health-related quality of life.3 However, limited number of patients can benefit from respiratory rehabilitation due to various reasons such as lack of resources and motivation as well as accessibility problems. The insufficient number of rehabilitation centers and the fact that most centers are located in city centers create a significant limitation. In this respect, telemedicine-based rehabilitation can significantly facilitate the access of elderly population who have difficulty leaving their homes and who do not have access to these services due to the aforementioned factors. 3, 4, 5 The studies in literature report that rehabilitation utilizing technology performed in the home environment significantly improves the exercise capacity and quality of life of patients. 6, 7, 8 In this study, the investigators aimed to develop an alternative rehabilitation program for patients with COPD who can't access traditional rehabilitation applications. The effects of this developed mobile application-based program on the participants were evaluated statistically.
  2. Methods In the present study, a mobile application that provided breathing and strengthening exercise training was developed to support the self-management of populations with COPD and to ensure their participation and continuity in an exercise program in their home environment. This application was developed with an aim to improve the dyspnea levels of populations with COPD, increase their exercise capacity, and improve their quality of life.

The study was a pre-test-post-test experimental study. The study was conducted on populations with COPD who presented to the pulmonary diseases clinic in a state hospital in a province. The study was carried out between October 2019 and June 2021, and the patients were followed at home for 10 weeks after exercise and self-management training.

The population of the study consisted of participants who were diagnosed with COPD and had no physical disability for exercise. Power analysis was performed to calculate the sample size. When α error was considered as 0.05 and the effect size was considered as 0.8, the sample size was determined to be 68 patients with COPD (34 in the experimental and 34 in the control group) with 90% power. However, considering that there would be dropouts, forty participants were included in both of the groups.

Patient Involvement: Patients aged 40 and over with COPD, who did not participate in the PR program during the last year and volunteered to participate in the study were included in the study. Patients with communication, mental, neurological and cognitive problems and those with disabilities to exercise were excluded from the study. The group that had a smartphone, met the inclusion criteria and volunteered to participate in the study was assigned to the experimental group. Participants who did not have a smartphone but, met the inclusion criteria were assigned to the control group. In addition, randomization was not performed. Assignment procedures to control and experimental groups were made by the researchers.The participants , who applied to the clinic during the study and met the criteria were assigned to the experimental and control groups until the number was completed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Experimental and control groups were evaluated separately. There was no need for blinding.

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants;
  • Beıng 40 years or older,
  • Not to have partıcıpated ın the PR program durıng the last year,
  • Volunteering to partıcıpate ın the study,
  • Beıng dıagnosed wıth COPD,
  • Not having a condition that prevents you from exercising,
  • In addıtıon, for the experiment group, ıt ıs necessary to have a smart phone for hımself or a close person.

排除标准

  • Participants; Have a communication problem,
  • Having mental or neurological problems,
  • Having arthritis, advanced cardiovascular disease, and critical pulmonary hypertension.

结局指标

主要结局

Dyspnea

时间窗: 10 weeks

Modified Medical Research Counsel (mMRC) and modified borg dyspnea scales were used to determine the effect of respiratory strengthening exercises. Modified borg dyspnea scale;This scale is used to measure the degree of difficulty in breathing. Individuals are asked to rate their shortness of breath between 0 and 10. 0 means that breathing does not cause any difficulty, and 10 points mean that shortness of breath is maximum. The mMRC (Modified Medical Research Council) Dyspnoea Scale is used to assess the degree of baseline functional disability due to dyspnoea. mMrc scale in daily activities a short scale used to rate the effects of shortness of breath.There is a scoring table between 0 and 4 points. 0 represents shortness of breath only during exercise, while 4 points; indicates the most severe shortness of breath.

Respiratory quality of life

时间窗: 10 weeks

St. George's Respiratory Questionnaire (SGRQ);Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.SGRQ This questionnaire consists of three sections: symptom, activity, and effects of the disease. The symptom section includes dyspnea, cough, sputum, and respiratory problems. The activity section investigates physical activities that are restricted due to shortness of breath. In the impact section, the effects of the disease on the daily life of the individual are assessed. The score range of the questionnaire is between 0 (perfect health) and 100 (most severe disease). A change of four units in the score is considered clinically significant. The total score is determined by adding up the scores of the three sections and dividing it by 100.

次要结局

未报告次要终点

研究者

发起方
T.C. ORDU ÜNİVERSİTESİ
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayten

Phd,Rn,lecturer

T.C. ORDU ÜNİVERSİTESİ

研究点 (4)

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