Fatigue Before and After Exercise in Patients With Advanced Cancer Stage

August 10, 2015 updated by: Adriana Silva Martins Ferreira, Barretos Cancer Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. - shoulder flexion 0-180º;
  2. - shoulder abduction and adduction;
  3. - shoulder extension;
  4. - elbow flexion;
  5. - 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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Barretos, SP, Brazil, 14784400
        • Recruiting
        • São Judas Tadeu Hospital
        • Contact:
        • Principal Investigator:
          • Adriana S Ferreira, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 minute walk
10-minute walk and exercises for the upper limbs with 1 lb-dumbbells
Other: 10 minute walk
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.
Other Names:
  • 10 minute walk and exercises
Experimental: 20 minute walk
20-minute walk and exercises for the upper limbs with 1 lb-dumbbells
Other: 20 minute walk
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.
Other Names:
  • 20 minute walk and exercises
Experimental: 30 minute walk
30-minute walk and exercises for the upper limbs with 1 lb-dumbbells
Other: 30 minute walk
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.
Other Names:
  • 30 minute walk and exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Baseline, 7 days, 14 days and 20 days after starting the intervention.
ESAS score and FACT-F questionnaire.
Baseline, 7 days, 14 days and 20 days after starting the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Baseline, 7 days, 14 days and 20 days after starting the intervention.
EORTC QLQ-C30.
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.
Anxiety & Depression Hospital Anxiety Depression scale (HADS)
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
Satisfaction-PGIC.
Baseline and 7 days after starting the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Investigators

  • Principal Investigator: Adriana M Ferreira, PhD, Barretos Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fatigue-hcb-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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