Fatigue Before and After Exercise in Patients With Advanced Cancer Stage

Not Applicable

• Conditions: Fatigue
• Interventions: Other: 30 minute walk; Other: 20 minute walk; Other: 10 minute walk

• Registration Number: NCT01581216
• Lead Sponsor: Barretos Cancer Hospital

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:

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-20
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 minute walk	30 minute walk	30-minute walk and exercises for the upper limbs with 1 lb-dumbbells
20 minute walk	20 minute walk	20-minute walk and exercises for the upper limbs with 1 lb-dumbbells
10 minute walk	10 minute walk	10-minute walk and exercises for the upper limbs with 1 lb-dumbbells

Primary Outcome Measures

Name	Time	Method
Fatigue	Baseline, 7 days, 14 days and 20 days after starting the intervention.	ESAS score and FACT-F questionnaire.

Secondary Outcome Measures

Name	Time	Method
Quality of life	Baseline, 7 days, 14 days and 20 days after starting the intervention.	EORTC QLQ-C30.
Anxiety and Depression Evaluation	Baseline, 7 days, 14 days and 20 days after starting the intervention.	Anxiety \& Depression Hospital Anxiety Depression scale (HADS)
Patient impression satisfaction	Baseline and 7 days after starting the intervention	Satisfaction-PGIC.

Trial Locations

Locations (1)

São Judas Tadeu Hospital; 🇧🇷 Barretos, SP, Brazil