跳至主要内容
临床试验/NCT04547634
NCT04547634已完成不适用

Effect of a Telerehabilitation-exercise Intervention in Oncology Patients in the Covid-19 Pandemic

University of Malaga2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Suitability of exercise intensity

研究概览

简要总结

The aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors

详细描述

Current literature shows that Therapeutic Exercise has multiple benefits in oncology patients, such as improvements in function and quality of life, and ameliorates symptoms such as cancer-related fatigue. Furthermore, given the risk of obesity, both exercise and diet play a key role in recovery from cancer. In fact, current guidelines support the use of exercise with therapeutic purposes as a complement to cancer treatment.

As a consequence of the COVID-19 pandemic, oncology patients present more difficulties to attend programs, as the vast majority are immunosuppressed, and they are considered risk population. Therefore, new online (TEEP) must be developed to facilitate the benefits of these programs in the post-COVID Era. This study analyses the feasibility (in terms of suitability and verification of exercise prescription, absence and attendance type, and total days of attendance) and the effect (in weight, physical function, and symptoms) in cancer patients and survivors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Metastatic breast patient, gynecological cancer patient, or breast cancer survivor under adjuvant treatment after surgical intervention.
  • Having given informed consent to participate voluntarily in the program and to be in contact via telematics (email or messaging platform).
  • Have a good internet connection
  • Be accompanied by an adult on the day of assessment.
  • Availability to access the computer on during the intervention.

排除标准

  • Technophobia
  • Domatophobia or self-report of adversity to be at home.
  • Lack of logistical requirements (Internet and lack of skill in its use).

研究组 & 干预措施

Experimental

Experimental

The sample will receive of a Therapeutic Exercise and Education programme

干预措施: Therapeutic Exercise and Education (Other)

Control

No Intervention

Subjects will be told to continue with their normal activity of daily living. After the intervention in the experimental group, the control group will be offered intervention.

结局指标

主要结局

Suitability of exercise intensity

时间窗: Through study completion, an average of 3 months

Patients are asked before each session to mark in a numerical scale how are they feeling that day to push themselves and get their session well done. From 0 (very well) to 10 (very badly). Higher scores mean a worse feeling.

Verification of exercise intensity

时间窗: Through study completion, an average of 3 months

Patients are asked to score the feeling of perceived effort after the session with the Borg Perceived Exertion scale (6-20). Higher scores mean a worse perceived exertion.

Total attendance

时间窗: After intervention, an average of 3 months

Total of days of attendance

Absence type

时间窗: Through study completion, an average of 3 months

Reasons of absence, categorized as: personal matter, visit the oncology, medical appointment (no related to oncology treatment), health problem, connection problem or unknown.

Attendance type

时间窗: Through study completion, an average of 3 months

Attendance type, categorized as: full attendance, partly attendance because of lack of time, partly attendance because of internet connection problem

次要结局

  • Change from Upper limb functionality (%)(prior and after intervention, an average of 3 months)
  • Change from Quality of life (self-reported questionnaire)(prior and after intervention, an average of 3 months)
  • Change from Cancer-Related Fatigue (CRF)(Prior and after intervention, an average of 3 months)
  • Change from Functional capacity(prior and after intervention, an average of 3 months)
  • Change from Lower limb functionality (%)(prior and after intervention, an average of 3 months)
  • Change from specific Breast Cancer Quality of life (self-reported questionnaire)(prior and after intervention, an average of 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Antonio I Cuesta-Vargas

Principal Researcher of CTS631 University of Malaga

University of Malaga

研究点 (2)

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