Pedometers and Walking Tests for Pulmonary Hypertension Patients: a First, Prospective Psychology and Concordance Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The patient's discordance category as precisely defined here:
研究概览
简要总结
Concordance between walking tests and pedometer data may seem like a logical outcome for pulmonary hypertension (PH) patients. However, many individuals have discordant results: results much worse or better during an in-hospital walking test as compared to real life activity.
The primary objective of this study is: to determine variables associated with discordance between the distance walked during an in-hospital 6-minute walking test (6MWT) and the average distance travelled per day (observed over a period of 28 days (2 × 14 days) using a pedometer) among PH patients.
详细描述
Secondarily, the discordance between 6MWT results versus total pedometer recorded distance and versus maximum daily pedometer-recorded distance will be similarly studied. The aim of the study is also to search for variables associated with progression free survival. The relationships between pedometer data and self-reported dyspnea variation will be studied. Factorial analysis may be used to study the overall view of variable correlations and patient similarity/dissimilarity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with idiopathic pulmonary hypertension (PH), familial PH, or PH associated with various pathologies (groups I to IV of the international classification)
- •New York Heart Association (NYHA) severity classes II to IV
- •Incident cases, or prevalent cases with stable disease over the last 3 months
- •Collection of informed written consent
- •Affiliation with or beneficiary of a social security program (health insurance)
- •Outpatient consulting at the hospital on the day of inclusion
- •6 minute walking test on day of inclusion
排除标准
- •Patients protected or unable to give consent according to Article L1121-8 of the French Public Health Code (CSP)
- •Pregnant or lactating women according to article L1121-5 of the CSP
- •Vulnerable persons according to article L1121-6 of the CSP
- •Simultaneous participation in any other research protocol
- •It is impossible to correctly inform the patient (language barrier, etc.)
- •The patient has already been included in the study
结局指标
主要结局
The patient's discordance category as precisely defined here:
时间窗: 74 days
Linear regression is performed for the distance walked during an initial 6 minute walking test (6MWT) and the average distance walked per day according to the pedometer intervention. The residuals from this regression will determine categories: Category 1 (pedometer high): the 25% of subjects not in category 2 and with higher values for pedometer data Category 2 (concordance): the 50% of included subjects with the smallest residuals in terms of absolute value. Category 3 (6MWT high): the 25% of subjects not in category 2 and with higher values for 6MWT data
次要结局
- Coping with Health Injuries and Problems Scale(Month 3)
- Multidimensional Fatigue Inventory (MFI)-20 questionnaire(Month 3)
- Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))(Month 3)
- Hospital Anxiety and Depression (HAD) scale(Month 3)
- State-Trait Anxiety Inventory (STAI) questionnaire(Month 3)