跳至主要内容
临床试验/NCT04518488
NCT04518488Unknown不适用

Starting Recovery Pre-operatively: Feasibility of Implementing Individualized Prehabilitation for People Scheduled for Lower Limb Soft-tissue Sarcoma Surgery

McGill University0 个研究点目标入组 30 人开始时间: 2020年9月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Daily step count

研究概览

简要总结

This study is about preparing people with cancerous tumours, soft-tissue sarcoma (STS), in the leg to recover more quickly from surgery. Prehabilitation or "surgery school" is done before surgery while undergoing other cancer-related treatments. To test this idea, two groups will be formed. One group will have the prehabilitation program and the other group will have the same amount of attention from the research team who will visit them at the time of the radiotherapy sessions to provide support and any information they may need.The results of the study will indicate whether it is a good idea to conduct a bigger study that would involve many centres in Canada.

详细描述

This study is about preparing people with cancerous tumours, soft-tissue sarcoma (STS), in the leg to recover more quickly from surgery. Prehabilitation or "surgery school" is done before surgery while undergoing other cancer-related treatments. The tumour can be anywhere in the leg so exercises must be specially designed for each person. This process is novel and therefore has to be tested to see if it is practical and if it helps people recovery more quickly. To test this idea, two groups will be formed. One group will have the prehabilitation program and the other group will have the same amount of attention from the research team who will visit them at the time of the radiotherapy sessions to provide support and any information they may need. Assessments of how well participants can do basic activities of daily living will be assessed at study entry, just prior to surgery and then at 2, 6 and 12 weeks after surgery. Other measures of recovery will be distance covered while walking for six minutes, quality of the walking, and how quickly participants can walk outdoors for 1000 steps, and then 3000, 5000 and 9000. The investigators will ask participants which of these outcome measures they think best reflected their recovery and why. The investigators will also assess whether people were willing to enter the study and complete all the processes required. The results of the study will indicate whether it is a good idea to conduct a bigger study that would involve many centres in Canada.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Deep lower extremity Soft-tissue Sarcoma (buttock to foot)
  • Histologically or cytologically-proven Soft-tissue Sarcoma (excluding superficial location) of the lower extremity.

排除标准

  • Patients with metastatic disease (distant or nodal)
  • both and upper and lower extremity involvement

结局指标

主要结局

Daily step count

时间窗: 12 weeks

will be obtained using the native accelerometer/gyroscope and pedometers available on both iphone (iOS) and android devices. For example, the android connection is through Google Fit

Change in Gait Quality (Angular velocity, cadence, heel strike)

时间窗: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.

Obtained through device placed on the shoe of participants

Change in Toronto Extremity Salvage Score

时间窗: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.

self-report measure comprising 30 items (0-100; 0 worse, 100 better outcome)

Change in Six-Minute Walk Test

时间窗: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.

Walking Capacity

次要结局

  • Change in health related quality of life(Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.)
  • Change in Edmonton Symptom Assessment Scale(Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.)
  • Change in individualized health related quality of life(Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.)

研究者

申办方类型
Other
责任方
Sponsor

相似试验