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

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ClinicalTrials.gov Identifier: NCT05059990
Recruitment Status : Not yet recruiting
First Posted : September 28, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Other: Low Intensity Aerobic Exercises Group Other: Active Exercises Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Low Intensity Aerobic Exercise and Active Exercises on Cancer Related Fatigue in Cancer Patients Receiving Palliative Care
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Intensity Aerobic Exercises Group
stationary cycle for aerobic exercise
Other: Low Intensity Aerobic Exercises Group
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 Comparator: Active Exercises Group
Upper and lower limb range of Motion (ROM) & stretching exercises uses in active exercise group
Other: Active Exercises 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




Primary Outcome Measures :
  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 you 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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05059990


Contacts
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Contact: Iqbal Tariq, MSCPPT 03338236752 iqbal.tariq@riphah.edu.pk
Contact: Imran Amjad, PhD +923324390125 imran.amjad@riphah.edu.pk

Locations
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Pakistan
Mubarak Hospital
Sargodha, Punjab, Pakistan, 40100
Contact: Iqbal Tariq, MSCPPT    03338236752    iqbal.tariq@riphah.edu.pk   
Contact: Ishrat Parveen, MSPT(CPPT)*    +92 301 7055447    ishoonawaz@gmail.com   
Principal Investigator: Ishrat Parveen, MSPT(CPPT)*         
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Muhammad Iqbal Tariq, MSCPPT Riphah International University
Principal Investigator: Abeer Fatima, MSCPPT Riphah International University
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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT05059990    
Other Study ID Numbers: Ishrat Perveen
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Low intensity Aerobic Exercise
ROM Exercise
Palliative Care