FatigueNCT01581216
Fatigue Before and After Exercise in Patients With Advanced Cancer Stage
A study testing 10 minute walk, 20 minute walk and 30 minute walk in people with Fatigue, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Fatigue related to cancer is the most common reported symptom and it prevents 91% of patients of having an active life, and in several cases, the fatigue persists for several months or even years after treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Fatigue
- What is being tested?
- 10 minute walk, 20 minute walk and 30 minute walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Dec 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be older than 18 years of age,
- Any gender
- Able to understand the study protocol,
- Functional capacity equal to or higher than 60, according to the Karnofsky scale,
- Patients with a life expectancy between 3 and 12 months,
- Patient able to ambulate independently without need for any orthotics.
Who cannot join
- Patients that use drugs in order to control fatigue (Methylphenidate, Modafinil),
- Anemic Patients (HB< 8.0 mg/dl),
- Patients with cognitive deficit,
- Uncontrolled pain higher than 5, according to Visual Analogue Scale (VAS),
- Patients currently exercising,
- Patients with congestive heart failure (CHF) (New York Heart Association functional class III or IV) or related angina.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
São Judas Tadeu Hospital
Barretos, São Paulo, 14784400
Adriana S Ferreira, PhD, +55-17-3321-6600 ext. 5528, asmferreira@yahoo.com.br
Adriana S Ferreira, PhD
About this study
Official title: The Use of Physical Activity to Control Fatigue and Improve the Quality of Life in Patients With Advanced Cancer Stage
Fatigue related to cancer is the most common reported symptom and it prevents 91% of patients of having an active life, and in several cases, the fatigue persists for several months or even years after treatment. Fatigue does cause an impact in all dimensions of patients' quality of life and it is the main cause of reduction in patients' daily life activities.
Fatigue is reported by cancer patients in all phases of the illness as one of the most frequent symptoms, especially in cases presenting metastases.
Read more
In order to monitor fatigue, pharmacological and non-pharmacological techniques may be employed, such as physical activity. Physical exercise has shown positive results in mitigating fatigue improving cardiopulmonary functioning, physical capacity and patients' quality of life.
This study will assess the efficiency of physical activity upon controlling the fatigue and quality of life in patients with advanced stage of the disease at the end of 7 days using FACT-F subscale.
Read the detailed description
Six minute walking test: a) Patients who walk a distance ≤ 300 meters in the 6-minute walk test will make a 10 minute walk once a day for 5 days for 4 weeks in a 30-feet long corridor located at the palliative care unit; b) Patients who walk 300-450 meters in the 6-minute walk test will make a 20 minute walk once a day for 5 days for 4 weeks in a 30-feet long corridor located at the palliative care unit; c) Patients who walk a distance less than 450 meters in the 6-minute walk test will make a 30 minute walk once a day for 5 days for 4 weeks in a 30-feet long corridor located at the palliative care unit.
Resistance exercise: Patient is assessed for the ability to use 1lb of dumbbell, if they are able to use easily then he has to use 2lb dumbbell. Dumbbell exercises during the first week are 10 repetitions, which will increase 10 repetitions per week, reaching a total of 40 repetitions on the last week. The exercises will be:
- - shoulder flexion 0-180º;
- - shoulder abduction and adduction;
- - shoulder extension;
- - elbow flexion;
- - wrist flexion and extension;
Patients' will have monitored their blood pressure, heart/cardiac frequency ( 40-60% of HR RESERVE or 60-70% HR MAX) and oxygen saturation by way of a finger oximeter made by Digit and perceived effort = light sweating, increase HR and breathing. Daily walk in the Borg scale at the beginning, middle and end will be applied to evaluate the fatigue of the patient.
- Conditions
- Fatigue
- Being tested
- 10 minute walk, 20 minute walk, 30 minute walk
- Keywords
- Fatigue, Palliative Care, Exercise
- Medical subject headings
- Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 minute walkOther
Also called 10 minute walk and exercises
Patients who walk a distance ≤ 300 meters in the 6-minute walk test will make a 10 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit.
20 minute walkOther
Also called 20 minute walk and exercises
Patients who walk 300-450 meters in the 6-minute walk test will make a 20 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit.
30 minute walkOther
Also called 30 minute walk and exercises
Patients who walk a distance less than 450 meters in the 6-minute walk test will make a 30 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit.
| Study group | Role | What they receive |
|---|---|---|
| 10 minute walk | Experimental | 10-minute walk and exercises for the upper limbs with 1 lb-dumbbells Receives: Other: 10 minute walk |
| 20 minute walk | Experimental | 20-minute walk and exercises for the upper limbs with 1 lb-dumbbells Receives: Other: 20 minute walk |
| 30 minute walk | Experimental | 30-minute walk and exercises for the upper limbs with 1 lb-dumbbells Receives: Other: 30 minute walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
ESAS score and FACT-F questionnaire.
Measured: Baseline, 7 days, 14 days and 20 days after starting the intervention.
Secondary outcomes (3)
Quality of life
EORTC QLQ-C30.
Measured: Baseline, 7 days, 14 days and 20 days after starting the intervention.
Anxiety and Depression Evaluation
Anxiety \& Depression Hospital Anxiety Depression scale (HADS)
Measured: Baseline, 7 days, 14 days and 20 days after starting the intervention.
Patient impression satisfaction
Satisfaction-PGIC.
Measured: Baseline and 7 days after starting the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Silva Martins Ferreira, Barretos Cancer Hospital
- Investigators
- Adriana M Ferreira, PhD, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581216
- Sponsor's protocol ID
- fatigue-hcb-01
- Status last verified
- Aug 2015
- First submitted
- 1 Feb 2012
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Physical Activity to Control Fatigue and Improve the Quality of Life in Patients With Advanced Cancer Stage
- ClinicalTrials.gov ID
- NCT01581216
- Acronym / sponsor ID
- fatigue-hcb-01
- Conditions
- Fatigue
- Keywords
- Fatigue, Palliative Care, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Apr 2012 (estimated)
- 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.
Fatigue related to cancer is the most common reported symptom and it prevents 91% of patients of having an active life, and in several cases, the fatigue persists for several months or even years after treatment. Fatigue does cause an impact in all dimensions of patients' quality of life and it is the main cause of reduction in patients' daily life activities.
Fatigue is reported by cancer patients in all phases of the illness as one of the most frequent symptoms, especially in cases presenting metastases.
In order to monitor fatigue, pharmacological and non-pharmacological techniques may be employed, such as physical activity. Physical exercise has shown positive results in mitigating fatigue improving cardiopulmonary functioning, physical capacity and patients' quality of life.
This study will assess the efficiency of physical activity upon controlling the fatigue and quality of life in patients with advanced stage of the disease at the end of 7 days using FACT-F subscale.
Detailed description
Six minute walking test: a) Patients who walk a distance ≤ 300 meters in the 6-minute walk test will make a 10 minute walk once a day for 5 days for 4 weeks in a 30-feet long corridor located at the palliative care unit; b) Patients who walk 300-450 meters in the 6-minute walk test will make a 20 minute walk once a day for 5 days for 4 weeks in a 30-feet long corridor located at the palliative care unit; c) Patients who walk a distance less than 450 meters in the 6-minute walk test will make a 30 minute walk once a day for 5 days for 4 weeks in a 30-feet long corridor located at the palliative care unit.
Resistance exercise: Patient is assessed for the ability to use 1lb of dumbbell, if they are able to use easily then he has to use 2lb dumbbell. Dumbbell exercises during the first week are 10 repetitions, which will increase 10 repetitions per week, reaching a total of 40 repetitions on the last week. The exercises will be:
- - shoulder flexion 0-180º;
- - shoulder abduction and adduction;
- - shoulder extension;
- - elbow flexion;
- - wrist flexion and extension;
Patients' will have monitored their blood pressure, heart/cardiac frequency ( 40-60% of HR RESERVE or 60-70% HR MAX) and oxygen saturation by way of a finger oximeter made by Digit and perceived effort = light sweating, increase HR and breathing. Daily walk in the Borg scale at the beginning, middle and end will be applied to evaluate the fatigue of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 minute walk | Experimental | Other: 10 minute walk10-minute walk and exercises for the upper limbs with 1 lb-dumbbells |
| 20 minute walk | Experimental | Other: 20 minute walk20-minute walk and exercises for the upper limbs with 1 lb-dumbbells |
| 30 minute walk | Experimental | Other: 30 minute walk30-minute walk and exercises for the upper limbs with 1 lb-dumbbells |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be older than 18 years of age,
- Any gender
- Able to understand the study protocol,
- Functional capacity equal to or higher than 60, according to the Karnofsky scale,
- Patients with a life expectancy between 3 and 12 months,
Key exclusion criteria (6 listed)
- Patients that use drugs in order to control fatigue (Methylphenidate, Modafinil),
- Anemic Patients (HB< 8.0 mg/dl),
- Patients with cognitive deficit,
- Uncontrolled pain higher than 5, according to Visual Analogue Scale (VAS),
- Patients currently exercising,
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 |
|---|---|---|
| 10 minute walkAlso: 10 minute walk and exercisesPatients who walk a distance ≤ 300 meters in the 6-minute walk test will make a 10 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit. | Other | 10 minute walk |
| 20 minute walkAlso: 20 minute walk and exercisesPatients who walk 300-450 meters in the 6-minute walk test will make a 20 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit. | Other | 20 minute walk |
| 30 minute walkAlso: 30 minute walk and exercisesPatients who walk a distance less than 450 meters in the 6-minute walk test will make a 30 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit. | Other | 30 minute walk |
Primary outcome
Fatigue
Time frame: Baseline, 7 days, 14 days and 20 days after starting the intervention.
ESAS score and FACT-F questionnaire.
3 secondary outcomes
Quality of life
Time frame: Baseline, 7 days, 14 days and 20 days after starting the intervention.
Anxiety and Depression Evaluation
Time frame: Baseline, 7 days, 14 days and 20 days after starting the intervention.
Patient impression satisfaction
Time frame: Baseline and 7 days after starting the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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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.
Adriana M Ferreira, PhD principal investigator
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 minute walk, 20 minute walk and 30 minute walk in people with Fatigue, run by Barretos Cancer Hospital at 1 site in Brazil.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Aug 2015. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriana S Ferreira, PhD (+55 17-3321-6600 ext. 5528, asmferreira@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Baseline, 7 days, 14 days and 20 days after starting the intervention.). 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 11 Aug 2015.