NCT04351815撤回不适用
Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months: a Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Hopital Foch
- 主要终点
- Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (6 minutes walk test)
研究概览
简要总结
This study aimed to evaluated the interest of a short-term (2 weeks) prehabilitation program compared to no prehabilitation before thoracic or urological surgery
详细描述
Prehabilitation is a form of global strength training, aims to improve functional capacity before surgery.This preparation compensate for its decrease due to the intervention. This process includes physical training, nutritional and psychological care.
Previous studies consider 4 weeks to be the ideal duration time for such program. However, extended program duration may reduce subject compliance and may not be possible for patient who can not or do not want to postponed their surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 55 or over
- •Requiring major surgery (thoracic or urological surgery: kidney or bladder) within 15 days after the completion of the inclusion assessment
- •Having signed a consent form after a reflection period
- •Being affiliated to a Health Insurance plan.
排除标准
- •Pregnant, parturient or lactating women
- •Persons deprived of their liberty: minors or adults subject to legal protection measures or out of state to express their consent
- •Patients (men or women) aged <55 years;
- •Inability to walk or initial physical assessment
- •Inability to complete questionnaires
- •Walk> 450 meters in the 6 minute test
- •Patients under guardianship or curators.
研究组 & 干预措施
Short prehabilitation
Experimental
This arm will benefit from a 2 weeks prehabilitation program including a personalized dietetic and physical training program as well as psychological support.
干预措施: Short term prehabilitation (2 weeks) (Behavioral)
No prehabilitation
Other
This arm will not benefit from a prehabilitation program before surgery. Patients will be told to maintain a regular physical activity without support.
干预措施: No specific intervention (Other)
结局指标
主要结局
Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (6 minutes walk test)
时间窗: 7 months
Change on the 6-minute walk test (distance covered over a time of 6 minutes in meters)
Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (Borg scale)
时间窗: 7 months
Change in the Borg scale (exertion from 0 to 10: 0 meaning no exertion, 10 meaning maximal exertion)
次要结局
- Evaluated the change in the muscular mass of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change in the muscular strength of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change in the body mass (weight) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change on the psychological state (sleep) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change in the body mass (lean mass) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change on the psychological state (quality of life) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change on the psychological state (anxiety and depression) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change in cardio-respiratory capacity (heart rate) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change on the psychological state (fatigue) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change in cardio-respiratory capacity (VO2 max) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change in cardio-respiratory capacity (spirometry: maximal voluntary ventilation) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change in cardio-respiratory capacity (spirometry: vital capacity) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change in cardio-respiratory capacity (spirometry: functional residual capacity) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change in cardio-respiratory capacity (heart rate) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change on the psychological state (pain) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change on the psychological state (geriatric health) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluated the change on the psychological state (daily living) of patient following a short prehabilitation at 15 days compared to the initial assessment(15 days)
- Evaluate compliance to the prehabilitation program(15 days)
- Evaluate post-surgery complications (classification)(2 months and 6 months)
- Evaluate post-surgery complications (length of stay)(2 months and 6 months)
- Evaluate post-surgery complications (mortality)(2 months and 6 months)
- Evaluate post-surgery complications (re-hospitalization)(2 months and 6 months)
- Evaluate post-surgery complications : comparison between predicted complications and actual complications (ARISCAT)(2 months and 6 months)
- Evaluate post-surgery complications : comparison between predicted complications and actual complications (LEE)(2 months and 6 months)
- Evaluated the change in cardio-respiratory capacity (6 minutes walk test) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change in cardio-respiratory capacity (VO2 max) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change in cardio-respiratory capacity (spirometry: maximal voluntary ventilation) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change in cardio-respiratory capacity (spirometry: vital capacity) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change in cardio-respiratory capacity (spirometry: functional residual capacity) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSPOM)(2 months and 6 months)
- Evaluate post-surgery complications : comparison between predicted complications and actual complications (Charlson index)(2 months and 6 months)
- Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSSUM score)(2 months and 6 months)
- Evaluated the change in the muscular strength of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change in the body mass (weight) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change in the muscular mass of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change in the body mass (lean mass) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change on the psychological state (quality of life) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change on the psychological state (anxiety and depression) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change on the psychological state (fatigue) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change on the psychological state (sleep) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change on the psychological state (pain) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change on the psychological state (geriatric health) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the change on the psychological state (daily living) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment(2 months and 6 months)
- Evaluated the compliance to the prehabilitation program(2 months and 6 months)
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