Fatigue Before and After Exercise in Patients With Advanced Cancer Stage

This study is currently recruiting participants.
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

February 1, 2012
March 20, 2014
December 2011
December 2014   (final data collection date for primary outcome measure)
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.
Fatigue [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Fatigue will be assessed by means of ESAS score and FACT-F questionnaire. The outcome will be measured 1 day before starting the intervention (exercises and walking), 2 weeks and 4 weeks after starting the intervention.
Complete list of historical versions of study NCT01581216 on ClinicalTrials.gov Archive Site
  • 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.
Quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Quality of life will be assessed by means of EORTC-QLQ-C30. This instrument produces a score (quantitative variable). Quality of life will be measured 1 day before starting the intervention, 2 weeks and 4 weeks after starting the intervention.
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fatigue
  • 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
  • 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
  • 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
  • Experimental: 10 minute walk
    10-minute walk and exercises for the upper limbs with 1 lb-dumbbells
    Intervention: Other: 10 minute walk
  • Experimental: 20 minute walk
    20-minute walk and exercises for the upper limbs with 1 lb-dumbbells
    Intervention: Other: 20 minute walk
  • Experimental: 30 minute walk
    30-minute walk and exercises for the upper limbs with 1 lb-dumbbells
    Intervention: Other: 30 minute walk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Adriana S Ferreira, PhD +55 17-3321-6600 ext 5528 asmferreira@yahoo.com.br
Brazil
 
NCT01581216
fatigue-hcb-01
No
Adriana Silva Martins Ferreira, Barretos Cancer Hospital
Barretos Cancer Hospital
Not Provided
Principal Investigator: Adriana M Ferreira, PhD Barretos Cancer Hospital
Barretos Cancer Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP