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临床试验/NCT06756230
NCT06756230招募中不适用

Effects of Downhill Walking in Pulmonary Rehabilitation for Patients With Idiopathic Pulmonary Fibrosis

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年5月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
34
试验地点
1
主要终点
6 Minutes Walking Distance (6MWD)

研究概览

简要总结

In this study; will examine the effects of downhill walking (eccentric exercise training) on exercise capacity, quality of life, and blood lactate levels in individuals with IPF. After the initial assessment, patients will be randomized into two groups: downhill walking PR group and Standard PR Group.

详细描述

Individuals diagnosed with idiopathic pulmonary fibrosis who come to the Pulmonary Rehabilitation Unit of Istanbul Süreyyapaşa Chest Diseases and Chest Surgery Education and Research Hospital will be included in this study. Those who meet the inclusion criteria will be randomized into two groups: Downhill Walking Pr Group (n=17) and Standard Pr Group (n=17). Patients will have exercise sessions twice a week for 8 weeks. Patients will be evaluated immediately before the rehabilitation program and the end of 8 weeks exercise programme. In our study, downhill walking training will differ from traditional walking training only in terms of treadmill training protocol. Traditional walking training involves walking on a motorized treadmill with a neutral incline, progressing with increases in speed, while downhill walking training will be performed at a constant -10% incline.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Having a diagnosis of IPF according to the clinical diagnostic criteria of the American Thoracic Society and/or the European Respiratory Society (ATS-ERS).
  • •Being between the ages of 18 and
  • •Being able to walk on a treadmill.
  • •Having the ability to cooperate.
  • •No change in current medication in the last month.
  • •Not participating in a structured activity program for at least six months.
  • •Accepting the purpose and method of this study voluntarily and give informed consent for the study.

排除标准

  • •Presence of physical or mental impairment that prevents informed consent or compliance with the protocol.
  • •Inability to attend more than 20% of pulmonary rehabilitation sessions.
  • •Presence of major cardiovascular disease (coronary artery disease, uncontrolled hypertension, arrhythmias, or heart failure).
  • •Presence of existing orthopedic and neuromuscular exercise limitations.
  • •Acute exacerbation

研究组 & 干预措施

Downhill Walking PR Group

Active Comparator

A standard pulmonary rehabilitation (PR) exercise program will be implemented. Downhill treadmill walking will be included during walking sessions.

干预措施: Pulmonary Rehabilitation (Other)

Downhill Walking PR Group

Active Comparator

A standard pulmonary rehabilitation (PR) exercise program will be implemented. Downhill treadmill walking will be included during walking sessions.

干预措施: Downhill Walking (Other)

Standard PR group

Active Comparator

A standard pulmonary rehabilitation (PR) exercise program will be implemented. Walking will be performed on a treadmill without incline.

干预措施: Pulmonary Rehabilitation (Other)

Standard PR group

Active Comparator

A standard pulmonary rehabilitation (PR) exercise program will be implemented. Walking will be performed on a treadmill without incline.

干预措施: Treadmill Walking without incline (Other)

结局指标

主要结局

6 Minutes Walking Distance (6MWD)

时间窗: Baseline and the end of the 8 weeks exercise program

6 MWD means the distance the patient walked in 6 minute walk test. Its unit is meters.

Saint George Quality of life questionnaire

时间窗: Baseline and the end of the 8 weeks exercise program

The St. George's Respiratory Questionnaire (SGRQ) is designed to measure quality of life. Four scores are calculated Symptoms, Activity, Impacts, and Total. Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

次要结局

  • Peripheral muscle strength(Baseline and the end of the 8 weeks exercise program)
  • Fatigue severity scale(Baseline and the end of the 8 weeks exercise program)
  • Spirometric measurements (First second forced expiratory volume)(Baseline and the end of the 8 weeks exercise program)
  • Spirometric measurements (FEV1/FVC ratio)(Baseline and the end of the 8 weeks exercise program)
  • Spirometric measurements (Forced vital capacity)(Baseline and the end of the 8 weeks exercise program)
  • Hand grip strength(Baseline and the end of the 8 weeks exercise program)
  • Modified Medical Research Council Dyspnea Score(Baseline and the end of the 8 weeks exercise program)
  • Hospital anxiety depression scale (HADS)(Baseline and the end of the 8 weeks exercise program)
  • Determination of blood lactate level(Baseline and the end of the 8 weeks exercise program)
  • Carbon monoxide diffusion capacity(Baseline and the end of the 8 weeks exercise program)

研究者

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

ESRA PEHLIVAN

Associate Professor

Saglik Bilimleri Universitesi

研究点 (1)

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