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临床试验/CTRI/2024/06/069472
CTRI/2024/06/069472尚未招募3 期

Effect of pre-operative exercise training in resectable esophageal cancer- a feasibility study

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月16日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
70
试验地点
1
主要终点
To check the feasibility and adherence to supervised exercise training in pre-operative stage.

研究概览

简要总结

The need for this study to evaluate the feasibility of supervised exercises for operable esophageal cancers and its effect on functional status. Patients will be evaluated before starting of any cancer treatment, after exercise intervention completion and post-operatively before discharge. All adults of any age diagnosed with esophageal cancer and planned for surgery and preoperative therapy, willing to give informed consent, willing to attend Physiotherapy department for exercises and who are fit to undertake mild to moderate exercise interventions will be included in the study. Patients with cognitive impairment, advanced disease, not able to complete baseline physical fitness test will be excluded. Physical fitness will be assessed on the basis of 6-minute walk test, grip strength, and spirometer while Quality of life will be measured by patient reported questionnaires such as EORTC QLQ-C-30 and EORTC QLQ-OES-18. (available in English, Hindi and Marathi)

After all the preliminary physical evaluations participants will be engaged in supervised exercise training under qualified Physiotherapist. This training will be given in the Physiotherapy department under controlled conditions for at least three days in a week for 12-14 sessions. Exercise session will include low intensity mixed type of exercises. Aerobic training will be given using active-passive trainer in the form of cycling while resistance exercises will be given using thera-tubing for both upper and lower limbs Pre and post vital parameters and Rate of perceived exertion (RPE) will be checked in every session. During rest of the day’s patients will be doing aerobic exercises in the form walking (on the basis of Borg rating of perceived exertion scale between 12-14) for at least 30 minutes as a home program along with conventional breathing exercises and spirometer. After supervised session home program will be given which includes walking and resistance training by using own body weight .Participants need to perform this exercises till surgery.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • participants with age 18 years and above, able to read, and medically fit to undergo exercise trial.

排除标准

  • participants with age 80 and above, with any neurological, orthopedic condition that hamper to undergo exercise training, and with advanced disease.

结局指标

主要结局

To check the feasibility and adherence to supervised exercise training in pre-operative stage.

时间窗: All outcomes will be assessed at pre-treatment (before intervention), after 12 to 14 sessions of intervention, post operatively between (7 to 10 days) before discharge. Feasibility will be recorded in terms of lost to follow up, attended number of sessions, permanent discontinuation of training, treatment interruption (miss≥ 3 consecutive sessions)

次要结局

  • Effect of preoperative exercise training on postoperative complications on the basis of Clavein-Dindo classification and length of stay in the hospital.(To assess the effect of supervised exercise training on 6-minute walk distance.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Manali Kamat

Tata Memorial Hospital

研究点 (1)

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