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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Low Intensity Aerobic Exercises Group; Other: Active Exercises Group

• Registration Number: NCT05059990
• Lead Sponsor: Riphah International University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-18
• Study First Submitted QC: 2021-09-18
• Study First Posted: 2021-09-28
• Study Start: 2021-10-10
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Intensity Aerobic Exercises Group	Low Intensity Aerobic Exercises Group	stationary cycle for aerobic exercise
Active Exercises Group	Active Exercises Group	Upper and lower limb range of Motion (ROM) \& stretching exercises uses in active exercise group

Primary Outcome Measures

Name	Time	Method
Brief Fatigue Inventory (BFI):	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
Karnofsky Performance Status	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
Edmonton Symptom Assessment Scale (ESAS)	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
Fatigue Numeric Rating Scale	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

Secondary Outcome Measures

Name	Time	Method
Quality of life questionnaire for cancer patients treated with anti-cancer drugs (QOL-ACD):	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

Trial Locations

Locations (1)

Mubarak Hospital; 🇵🇰 Sargodha, Punjab, Pakistan