Low Intensity Aerobic Exercise and Active Exercises in Cancer Patients Receiving Palliative Care

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Low Intensity Aerobic Exercise and Active Exercises on Cancer Related Fatigue in Cancer Patients Receiving Palliative Care

Conditions
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Cancer

Intervention / Treatment
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* Other: Low Intensity Aerobic Exercises Group
* Other: Active Exercises Group


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Intensity Aerobic Exercises Group<br>stationary cycle for aerobic exercise | Other: Low Intensity Aerobic Exercises Group<br>* 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<br>|
| Active Comparator: Active Exercises Group<br>Upper and lower limb range of Motion (ROM) & stretching exercises uses in active exercise group | Other: Active Exercises Group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Numeric Rating Scale | 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 | 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) | 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): | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire for cancer patients treated with anti-cancer drugs (QOL-ACD): | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low intensity Aerobic Exercise, ROM Exercise, Palliative Care