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Fatigue Before and After Exercise in Patients With Advanced Cancer Stage

Primary Purpose

Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
10 minute walk
20 minute walk
30 minute walk
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Fatigue, Palliative Care, Exercise

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • São Judas Tadeu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

10 minute walk

20 minute walk

30 minute walk

Arm Description

10-minute walk and exercises for the upper limbs with 1 lb-dumbbells

20-minute walk and exercises for the upper limbs with 1 lb-dumbbells

30-minute walk and exercises for the upper limbs with 1 lb-dumbbells

Outcomes

Primary Outcome Measures

Fatigue
ESAS score and FACT-F questionnaire.

Secondary Outcome Measures

Quality of life
EORTC QLQ-C30.
Anxiety and Depression Evaluation
Anxiety & Depression Hospital Anxiety Depression scale (HADS)
Patient impression satisfaction
Satisfaction-PGIC.

Full Information

First Posted
February 1, 2012
Last Updated
August 10, 2015
Sponsor
Barretos Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01581216
Brief Title
Fatigue Before and After Exercise in Patients With Advanced Cancer Stage
Official Title
The Use of Physical Activity to Control Fatigue and Improve the Quality of Life in Patients With Advanced Cancer Stage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barretos Cancer Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Fatigue, Palliative Care, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10 minute walk
Arm Type
Experimental
Arm Description
10-minute walk and exercises for the upper limbs with 1 lb-dumbbells
Arm Title
20 minute walk
Arm Type
Experimental
Arm Description
20-minute walk and exercises for the upper limbs with 1 lb-dumbbells
Arm Title
30 minute walk
Arm Type
Experimental
Arm Description
30-minute walk and exercises for the upper limbs with 1 lb-dumbbells
Intervention Type
Other
Intervention Name(s)
10 minute walk
Other Intervention Name(s)
10 minute walk and exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
20 minute walk
Other Intervention Name(s)
20 minute walk and exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
30 minute walk
Other Intervention Name(s)
30 minute walk and exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue
Description
ESAS score and FACT-F questionnaire.
Time Frame
Baseline, 7 days, 14 days and 20 days after starting the intervention.
Secondary Outcome Measure Information:
Title
Quality of life
Description
EORTC QLQ-C30.
Time Frame
Baseline, 7 days, 14 days and 20 days after starting the intervention.
Title
Anxiety and Depression Evaluation
Description
Anxiety & Depression Hospital Anxiety Depression scale (HADS)
Time Frame
Baseline, 7 days, 14 days and 20 days after starting the intervention.
Title
Patient impression satisfaction
Description
Satisfaction-PGIC.
Time Frame
Baseline and 7 days after starting the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana S Ferreira, PhD
Phone
+55 17-3321-6600
Ext
5528
Email
asmferreira@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana M Ferreira, PhD
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
São Judas Tadeu Hospital
City
Barretos
State/Province
SP
ZIP/Postal Code
14784400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana S Ferreira, PhD
Phone
+55-17-3321-6600
Ext
5528
Email
asmferreira@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Adriana S Ferreira, PhD

12. IPD Sharing Statement

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Fatigue Before and After Exercise in Patients With Advanced Cancer Stage

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