跳至主要内容
临床试验/NCT05147038
NCT05147038已完成不适用

The Impact of Tele-coaching on the Physical Activity Level in Patients With Chronic Respiratory Disease

Palacky University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Objective measurement of physical activity

研究概览

简要总结

The study aims to test the benefits of a semi-automated tele-coaching program to coach adult participants with chronic lung disease towards a more active lifestyle.

详细描述

The level of physical activity (PA) has been shown to be an important predictor for morbidity and mortality in individuals with chronic respiratory diseases, for instance Chronic Obstructive Pulmonary Disease (COPD) or Idiopathic Pulmonary Fibrosis (IPF). Physical inactivity and sedentary behavior is a common feature of patients with chronic respiratory diseases. Pulmonary rehabilitation is known as a beneficial intervention in exercise capacity, disease symptoms and quality of life in respiratory diseases. Despite the overall large benefits on exercise capacity and other variables described above, it does not automatically translate into increases in PA. Recent literature shows that coaching programs specifically aiming to increase PA are more likely to result in PA changes.

Therefore, this study was designed to investigate the impact of 3-month (12 weeks) tele-coaching intervention on PA level of adult participants suffering from a chronic lung disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

盲法说明

Neither patients nor investigators will be blinded for the allocation.

入排标准

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

入选标准

  • •Stable patients, older than 18 years of age, with a diagnosis of interstitial lung disease
  • •Understands and is able to work with a smart phone application (judged by the investigator)
  • •On stable pharmacotherapy
  • •Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥30%predicted

排除标准

  • •On the waiting list for a lung transplantation
  • •Life expectancy below 3 months
  • •Respiratory tract infection or an exacerbation or change in maintenance medication within 4 weeks before study enrolment
  • •Extra pulmonary impairments, unrelated to the underlying lung disease, interfering with physical activity

研究组 & 干预措施

Intervention group

Experimental

Participants allocated into the intervention group will be coached for 12 weeks by a tele-coaching mobile App containing tips for PA increase and for number of steps recording (visual feedback for the patient).

干预措施: Tele-coaching (Device)

Control group

No Intervention

Participants in the control group will receive usual care (including regular visits) together with the educational information.

结局指标

主要结局

Objective measurement of physical activity

时间窗: 12 weeks

Change in weekly mean step count 12 weeks post randomization in the intervention group as compared to the control group.

次要结局

  • Physical activity parameters(12 weeks)
  • Spirometry 1(12 weeks)
  • Spirometry 2(12 weeks)
  • Spirometry 3(12 weeks)
  • Six minute walk test(12 weeks)
  • Isometric Quadriceps force(12 weeks)
  • Questionnaire 1(12 weeks)
  • Questionnaire 2(12 weeks)
  • Questionnaire 3(12 weeks)
  • Questionnaire 4(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zdenek Svoboda

Tamara Zlamalova, Palacký University Olomouc, the Department of Physiotherapy, Principal Investigator, Ph.D. student

Palacky University

研究点 (1)

Loading locations...

相似试验