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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Low Intensity Aerobic Exercises Group; Other: Active Exercises Group

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Sargodha, Punjab, Pakistan, 40100
      • Mubarak Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Abeer Fatima, MSCPPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: September 18, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Palliative Care; Low intensity Aerobic Exercise; ROM Exercise
• Other Study ID Numbers: REC/01085 Ishrat Perveen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No