Validation of a Walk-Time Limit Test (WTLT) Derived from the 6-Minute Walk Test (6-MWT) in Patients with Chronic Cardiovascular or Respiratory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Endurance time
研究概览
简要总结
Many exercise tests are commonly used to evaluate the changes of exercise tolerance following rehabilitation programs in patients with chronic respiratory diseases.
Among the tests (6-MWT, incremental test, ...), the literature seems to indicate that endurance time is the most responsive parameter for detecting and quantifying changes in exercise capacity following a rehabilitation program. Although its clinical interest is undeniable, the endurance shuttle walking test is rarely used because it requires the prior performance of two incremental shuttle walking tests to determine the walking speed imposed on the patient.
In this protocol, we propose to test a Walk-Time Limit Test (WTLT) derived from the 6-minute walk test (6-MWT) and based on the average walking speed achieved in this test commonly used in the follow-up of patients with chronic diseases.
TTLM validation would improve the functional assessment of patients with chronic diseases while limiting the number of exercise tests.
详细描述
Each patient will perform 4 visits over a period of 4-week. Fifty subjects with COPD and fifty subjects with heart failure will be recruited for the same protocol.
During the first visit, the subject will realize two 6-MWT and a cardiopulmonary exercise test on ergocycle with the measure of cardiorespiratory parameters. We will evaluate the physical activity during daily life using an accelerometer and we will use several questionnaires to measure the quality of life, the motivation to physical activities and symptoms.
During the second visit, the subject will realize a 4-meter walk test, two incremental shuttle walk tests (ISWT), an endurance shuttle walk test (ESWT) and a test with dynamometer to measure the quadriceps strength.
During the third and fourth visits, the subject realize two or three endurance walking tests (Walk-Time Limit Test - WTLT) at a walking speed equivalent to the mean speed realize during the better 6MWT (visit 1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Respiratory Disease Group:
- •Diagnosis of COPD with FEV1 corresponding to stages GOLD II or III (50-80% predicted or 30-50% predicted, respectively).
- •Patient's agreement
- •Being older than 18
- •Stable treatment for 3 months
- •Subjects affiliated with social security
- •Group cardiovascular diseases:
- •Diagnosis of heart failure or stable coronary artery disease with NYHA Class II stage.
- •Patient's agreement
- •Being older than 18
- •Stable treatment for 3 months
- •Subjects affiliated with social security
排除标准
- •Any medical contraindications to the practice of a suitable physical activity
- •Presence of muscle, joint and / or neurological comorbidities affecting motor skills and test performance.
- •Refusal of the patient
- •Subject under guardianship or curatorship
- •Subject aged over 80 at the time of inclusion
- •Realization of a rehabilitation program during the study period
- •Subject under resting oxygen therapy
- •Diagnosis of heart failure, coronary artery disease or any cardiovascular pathology that required surgery.
- •Diagnosis of an associated chronic respiratory disease, such as asthma, pulmonary arterial hypertension or interstitial lung disease.
结局指标
主要结局
Endurance time
时间窗: 4 weeks
The patient walks at the same speed during the entire test in a corridor 10 meters long around studs placed at a distance of 9m
次要结局
- Walking distance to 6-MWT(0 day)
- Score of motivation thanks to Behavourial Regulation and Exercise Questionnaire 2 (BREQ-2)(0 day)
- Following of the quality of life(0 day)
- Number of steps by day (accelerometer)(7 days)
- Forced expiratory volume per second(0 Day)
- Forced Vital Capacity(0 day)
- Total Lung Capacity(0 day)
- Dyspnea and leg fatigue during tests after WTLT(7 days)
- heart rate(1 day)
- Maximum speed measured at the ISWT(0 day)
- carbon dioxide production(1 day)
- Maximum speed measured (4-meter walk test)(0 day)
- Oxygen consumption(1 day)
- Quadriceps strength(0 day)
- breathing frequency(1 day)
- Diffusing capacity for carbon monoxide(0 day)