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NCT Number: NCT05059990

Low Intensity Aerobic Exercise and Active Exercises 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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mubarak Hospital

Sargodha, Punjab Province, 40100, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low Intensity Aerobic Exercises Group

Other

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

Active Exercises Group

Other

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

Primary outcomes

  1. Fatigue Numeric Rating Scale

    Time frame: 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

  2. Karnofsky Performance Status

    Time frame: 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

  3. Edmonton Symptom Assessment Scale (ESAS)

    Time frame: 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. Brief Fatigue Inventory (BFI):

    Time frame: 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

Secondary outcomes

  1. Quality of life questionnaire for cancer patients treated with anti-cancer drugs (QOL-ACD):

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2021
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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