Low Intensity Aerobic Exercise and Active Exercises in Cancer Patients Receiving Palliative Care
2022年2月1日 更新者：Riphah International University
Comparison of Low Intensity Aerobic Exercise and Active Exercises on Cancer Related Fatigue in Cancer Patients Receiving Palliative Care
To compare the effect of low intensity aerobic exercise and active ROM exercises on cancer related fatigue and its associated symptoms and quality of life in cancer patients receiving palliative care.
研究概览
研究类型
介入性
注册 (实际的)
22
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Punjab
-
Sargodha、Punjab、巴基斯坦、40100
- Mubarak Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- ability to give written consent.
- Diagnosed advance cancer specifically gastrointestinal tract (GIT) cancer, Lung cancer and Breast cancer etc. (stage 2 and 3).
- Intensity of fatigue ≥4 out of 10 on fatigue Numerical Rating Scale in first visit observation
- Survival expectancy more than one month,
- Functional status allowing the participants to participate in the proposed therapy.
Exclusion Criteria:
- Anemia (Hb ≤ 8g/dl),
- Existence of other comorbidities causing fatigue (i.e. Parkinson's, Multiple sclerosis, Heart failure),
- Infection requiring antibodies
- bone metastases,
- thrombocytopenia (<50×109/l),
- myocardial infarction within the past three months
- uncontrolled hypertension (diastolic pressure >95 mm Hg).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Low Intensity Aerobic Exercises Group
stationary cycle for aerobic exercise
|
Intervention Low Intensity Aerobic Exercises i.e. stationary cycle(supervised) Intensity 55-65% of HRmax Frequency 3 times a week Duration 30 min each session
|
|
有源比较器：Active Exercises Group
Upper and lower limb range of Motion (ROM) & stretching exercises uses in active exercise group
|
Intervention Upper and lower limb ROM & stretching exercises Intensity As per tolerance Frequency 12 repetition/4sets per exercise 3 times/week Duration 30 minutes each session
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fatigue Numeric Rating Scale
大体时间：4th Week
|
The fatigue numeric rating scale (NRS) is a single-item measure assessing severity of fatigue.
We will use this in our study to measure the severity of cancer related fatigue in oncology patients receiving palliative care.
The fatigue NRS is a patient- administered, single- item, 11- point horizontal scale anchored at 0 and 10, with 0 representing 'no fatigue' and 10 representing 'as bad as participant can imagine'.
Changes from the baseline to 4 week
|
4th Week
|
|
Karnofsky Performance Status
大体时间：4 Week
|
The Karnofsky Performance Scale Index is an assessment tool for functional impairment.
It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients.
It is a standard way of measuring the ability of cancer patients to perform ordinary tasks.
The Karnofsky Performance Status scores range from 0 to 100.
A higher score means the patient is better able to carry out daily activities.
Changes from the baseline to 4 week
|
4 Week
|
|
Edmonton Symptom Assessment Scale (ESAS)
大体时间：4 week
|
This tool is designed to assess nine common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath.
The severity for each symptom ranges from 0 to 10 where 0 means absence of symptom to 10 being the worst possible severity.
Changes from the baseline to 4 week
|
4 week
|
|
Brief Fatigue Inventory (BFI):
大体时间：4 week
|
It is used to rapidly assess the severity and impact of cancer-related fatigue on daily functioning in past 24 hours, which requires a very short time to fill and the global fatigue scoring can be obtained by averaging all the 4 items on the BFI.
Changes from the baseline to 4 week
|
4 week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life questionnaire for cancer patients treated with anti-cancer drugs (QOL-ACD):
大体时间：4 week
|
Quality of Life Anti-Cancer Drugs (QOL-ACD) is a Quality-of-life measurement tool for patients undergoing chemotherapy it has 22 items, divided into these categories: daily activities, physical condition, social activities, mental and psychological status.
Scaling of items is from 5 to 1(5 being worst and 1 being good) for 21 items, and a five-point face scale for 1 item.
Changes from the baseline to 4 week
|
4 week
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Abeer Fatima, MSCPPT、Riphah International University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年10月10日
初级完成 (实际的)
2021年12月30日
研究完成 (实际的)
2021年12月30日
研究注册日期
首次提交
2021年9月18日
首先提交符合 QC 标准的
2021年9月18日
首次发布 (实际的)
2021年9月28日
研究记录更新
最后更新发布 (实际的)
2022年2月2日
上次提交的符合 QC 标准的更新
2022年2月1日
最后验证
2022年2月1日
更多信息
与本研究相关的术语
其他研究编号
- REC/01085 Ishrat Perveen
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.