Fatigue Before and After Exercise in Patients With Advanced Cancer Stage

NCT ID: NCT01581216

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-12-31

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.

Conditions

Fatigue

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

10 minute walk

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

Group Type: EXPERIMENTAL

10 minute walk

Intervention Type: OTHER

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.

20 minute walk

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

Group Type: EXPERIMENTAL

20 minute walk

Intervention Type: OTHER

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.

30 minute walk

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

Group Type: EXPERIMENTAL

30 minute walk

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

10 minute walk and exercises; 20 minute walk and exercises; 30 minute walk and exercises

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Adriana Silva Martins Ferreira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adriana M Ferreira, PhD

Role: PRINCIPAL_INVESTIGATOR

Barretos Cancer Hospital

Locations

São Judas Tadeu Hospital

Barretos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Adriana S Ferreira, PhD

Role: CONTACT

asmferreira@yahoo.com.br

+55 17-3321-6600 ext. 5528

Facility Contacts

Adriana S Ferreira, PhD

Role: primary

asmferreira@yahoo.com.br

+55-17-3321-6600 ext. 5528

Other Identifiers

fatigue-hcb-01

Identifier Type: -

Identifier Source: org_study_id