Study Comparing Two Strategies of Exercise in Breast and Colon Cancer Survivors and Their Impact on Fatigue

NCT ID: NCT02647398

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-09-30

Brief Summary

Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue.

Detailed Description

Patients should have finalized their oncological treatment in the previous 5 years. The sample size (32 patients) was calculated to improve the perception of fatigue score from an anticipated initial 38 to a post-intervention 48.

The control arm consist of supervised strength training in two sessions per week with non-supervised international recommendations for aerobic exercise. The experimental arm will consist of supervised strength + resistance training in two sessions per week.

After evaluating the weekly physical activity through accelerometer, body composition through DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training according to a randomized assignment.

Secondary objectives include:

1. cardiorespiratory fitness,

2. quality of life;

3. adherence to the training program;

4. adherence to international recommendations,

5. body composition,

6. employment status

Conditions

Neoplasms; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A: Supervised combined training

INTERVENTION: Two supervised 75 min-vigorous aerobic training \& strength training

Group Type: EXPERIMENTAL

Vigorous aerobic training

Intervention Type: BEHAVIORAL

Supervised vigorous aerobic training

B: Supervised strength training

ACTIVE COMPARATOR: Two supervised 45-minute sessions of strength training \& Participants will be advised to comply with international recommendations of physical activity (150 min pf MVPA)

Group Type: ACTIVE_COMPARATOR

Vigorous aerobic training

Intervention Type: BEHAVIORAL

Supervised vigorous aerobic training

Interventions

Vigorous aerobic training

Supervised vigorous aerobic training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-65
• history of breast or colon cancer
• no evidence of disease
• end of treatment in the last five years
• able to understand the questionnaire PERFORM
• able to manage the accelerometer

Exclusion Criteria

• mobility limitation
• treatment with beta-blockers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ana Ruiz-Casado

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Itziar Pagola, PhD

Role: STUDY_DIRECTOR

Universidad Europea de Madrid

Locations

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, Spain

Countries

Spain

Other Identifiers

PH-UEM-04

Identifier Type: -

Identifier Source: org_study_id