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

NCT05059990 | Completed DMC

• 1 other identifier: REC/01085 Ishrat Perveen
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Low intensity Aerobic Exercise; ROM Exercise; Palliative Care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

  4 week

Study Arms (2)

Low Intensity Aerobic Exercises Group

EXPERIMENTAL

stationary cycle for aerobic exercise

Other: Low Intensity Aerobic Exercises Group

Active Exercises Group

ACTIVE COMPARATOR

Upper and lower limb range of Motion (ROM) \& stretching exercises uses in active exercise group

Other: Active Exercises Group

Interventions

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

Low Intensity Aerobic Exercises Group

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

Active Exercises Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Mubarak Hospital

Sargodha, Punjab Province, 40100, Pakistan

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Muhammad Iqbal Tariq, MSCPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

• Abeer Fatima, MSCPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: September 28, 2021
• Study Start: October 10, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)