Fatigue Before and After Exercise in Patients With Advanced Cancer Stage
The Use of Physical Activity to Control Fatigue and Improve the Quality of Life in Patients With Advanced Cancer Stage
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 11, 2015
August 1, 2015
4 years
February 1, 2012
August 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue
ESAS score and FACT-F questionnaire.
Baseline, 7 days, 14 days and 20 days after starting the intervention.
Secondary Outcomes (3)
Quality of life
Baseline, 7 days, 14 days and 20 days after starting the intervention.
Anxiety and Depression Evaluation
Baseline, 7 days, 14 days and 20 days after starting the intervention.
Patient impression satisfaction
Baseline and 7 days after starting the intervention
Study Arms (3)
10 minute walk
EXPERIMENTAL10-minute walk and exercises for the upper limbs with 1 lb-dumbbells
20 minute walk
EXPERIMENTAL20-minute walk and exercises for the upper limbs with 1 lb-dumbbells
30 minute walk
EXPERIMENTAL30-minute walk and exercises for the upper limbs with 1 lb-dumbbells
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
São Judas Tadeu Hospital
Barretos, São Paulo, 14784400, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriana M Ferreira, PhD
Barretos Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 1, 2012
First Posted
April 20, 2012
Study Start
December 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
August 11, 2015
Record last verified: 2015-08