Fatigue Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | São Judas Tadeu Hospital | Barretos | SP |
Lead Sponsor | Collaborator |
---|---|
Barretos Cancer Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue | ESAS score and FACT-F questionnaire. | Baseline, 7 days, 14 days and 20 days after starting the intervention. | No |
Secondary | Quality of life | EORTC QLQ-C30. | Baseline, 7 days, 14 days and 20 days after starting the intervention. | No |
Secondary | Anxiety and Depression Evaluation | Anxiety & Depression Hospital Anxiety Depression scale (HADS) | Baseline, 7 days, 14 days and 20 days after starting the intervention. | No |
Secondary | Patient impression satisfaction | Satisfaction-PGIC. | Baseline and 7 days after starting the intervention | No |
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