Fatigue Before and After Exercise in Patients With Advanced Cancer Stage

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Barretos Cancer Hospital
Sponsor:
Information provided by (Responsible Party):
Adriana Silva Martins Ferreira, Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01581216
First received: February 1, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Fatigue
Other: 10 minute walk
Other: 20 minute walk
Other: 30 minute walk

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Physical Activity to Control Fatigue and Improve the Quality of Life in Patients With Advanced Cancer Stage

Resource links provided by NLM:


Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • Fatigue [ Time Frame: Baseline, 7 days, 14 days and 20 days after starting the intervention. ] [ Designated as safety issue: No ]
    ESAS score and FACT-F questionnaire.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Baseline, 7 days, 14 days and 20 days after starting the intervention. ] [ Designated as safety issue: No ]
    EORTC QLQ-C30.

  • Anxiety and Depression Evaluation [ Time Frame: Baseline, 7 days, 14 days and 20 days after starting the intervention. ] [ Designated as safety issue: No ]
    Anxiety & Depression Hospital Anxiety Depression scale (HADS)

  • Patient impression satisfaction [ Time Frame: Baseline and 7 days after starting the intervention ] [ Designated as safety issue: No ]
    Satisfaction-PGIC.


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 30 minute walk and exercises

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581216

Contacts
Contact: Adriana S Ferreira, PhD +55 17-3321-6600 ext 5528 asmferreira@yahoo.com.br

Locations
Brazil
São Judas Tadeu Hospital Recruiting
Barretos, SP, Brazil, 14784400
Contact: Adriana S Ferreira, PhD    +55-17-3321-6600 ext 5528    asmferreira@yahoo.com.br   
Principal Investigator: Adriana S Ferreira, PhD         
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
Principal Investigator: Adriana M Ferreira, PhD Barretos Cancer Hospital
  More Information

No publications provided

Responsible Party: Adriana Silva Martins Ferreira, Principal Investigator, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT01581216     History of Changes
Other Study ID Numbers: fatigue-hcb-01
Study First Received: February 1, 2012
Last Updated: March 20, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Barretos Cancer Hospital:
Fatigue
Palliative Care
Exercise

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014