CancerNCT05059990
Low Intensity Aerobic Exercise and Active Exercises in Cancer Patients Receiving Palliative Care
A study testing Low Intensity Aerobic Exercises Group and Active Exercises Group in people with Cancer, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer
- What is being tested?
- Low Intensity Aerobic Exercises Group and Active Exercises Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- Low Intensity Aerobic Exercises Group, Active Exercises Group
- Keywords
- Low intensity Aerobic Exercise, ROM Exercise, Palliative Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Aerobic Exercises GroupOther
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 GroupOther
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
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Aerobic Exercises Group | Experimental | stationary cycle for aerobic exercise Receives: 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 Receives: Other: Active Exercises Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 week
Secondary outcomes (1)
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
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start10 Oct 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, MSCPPT, Principal investigator, Riphah International UniversityAbeer Fatima, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059990
- Sponsor's protocol ID
- REC/01085 Ishrat Perveen
- Status last verified
- Feb 2022
- First submitted
- 18 Sep 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low Intensity Aerobic Exercise and Active Exercises on Cancer Related Fatigue in Cancer Patients Receiving Palliative Care
- ClinicalTrials.gov ID
- NCT05059990
- Acronym / sponsor ID
- REC/01085 Ishrat Perveen
- Conditions
- Cancer
- Keywords
- Low intensity Aerobic Exercise, ROM Exercise, Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Aerobic Exercises Group | Experimental | Other: Low Intensity Aerobic Exercises Groupstationary cycle for aerobic exercise |
| Active Exercises Group | Active comparator | Other: Active Exercises GroupUpper and lower limb range of Motion (ROM) \& stretching exercises uses in active exercise group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Intensity Aerobic Exercises GroupIntervention Low Intensity Aerobic Exercises i.e. stationary cycle(supervised) Intensity 55-65% of HRmax Frequency 3 times a week Duration 30 min each session | Other | Low Intensity Aerobic Exercises Group |
| Active Exercises GroupIntervention 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 | Other | Active Exercises Group |
Primary outcome
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
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
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
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
1 secondary outcome
Quality of life questionnaire for cancer patients treated with anti-cancer drugs (QOL-ACD):
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, MSCPPT principal investigator
Riphah International University
Abeer Fatima, MSCPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Aerobic Exercises Group and Active Exercises Group in people with Cancer, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Numeric Rating Scale (time frame: 4th Week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.