Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment

NCT02828189 | Completed DMC

• 1 other identifier: FPSM_UAH_VPG_2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to determine whether the proposed program of therapeutic exercise is effective in improving fatigue, more than the exercise unsupervised depending on their preferences, in women treated for breast cancer.

Conditions

Fatigue; Breast Cancer

Keywords

Physical Therapy Modalities; Breast Cancer Treatment; Exercise Therapy; Dyspnea

Outcome Measures

Primary Outcomes (1)

• Subjective assessment of perception of fatigue.

  FACIT-FatigueScale (total score)

  6 months

Secondary Outcomes (3)

• Subjective assessment of perception of dyspnoea

  6 months

• Distance in meters

  6 months

• Pain Intensity

  6 months

Study Arms (2)

Physical Exercise

ACTIVE COMPARATOR

The protocol consists in: * Physical Exercise according to their preferences. * Therapeutic Education related to Health Habits and Physical Exercise.

Other: Physical Exercise; Behavioral: Therapeutic Education

Therapeutic Exercise-Physiotherapy

EXPERIMENTAL

The protocol consists in: * Cardiovascular exercise. * Force-Resistance Exercises of the principals muscle groups of the lower limbs, upper limbs and trunk. * Muscle Stretches. * Therapeutic Education related to Health Habits and Physical Exercise.

Behavioral: Therapeutic Education; Other: Therapeutic exercise-Physiotherapy

Interventions

Physical Exercise OTHER

The patients were instructed to perform autonomous physical exercise program based preferences (progressive march on flat ground, dancing, cycling, etc.). They will receive written information. The program is 9 weeks with a frequency of 3 days per week and sessions about 50 minutes long.

Also known as: Exercise

Physical Exercise

Therapeutic Education BEHAVIORAL

Individual Therapeutic Education about healthy habits and exercise on breast cancer.

Also known as: Hygienic and behavioral advises

Physical Exercise; Therapeutic Exercise-Physiotherapy

Therapeutic exercise-Physiotherapy OTHER

1. Cardiovascular exercise 2. Individualized progressive strength and resistance exercises of principals muscle groups of the lower limbs, upper limbs and trunk. 3. Flexibilization exercises

Also known as: Physiotherapy exercise

Therapeutic Exercise-Physiotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women treated for breast cancer, completed at least 6 months before, with persistent fatigue.
• Women who do not present contraindications for physiotherapy and physical exercise (infection, metastasis, loco regional recurrence, cardiopulmonary disorders).
• Women who have read, understood and signed informed consent freely.

You may not qualify if:

• Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.

Alcalá de Henares, Madrid, 28871, Spain

Location

MeSH Terms

Conditions

Fatigue; Breast Neoplasms; Dyspnea

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Virginia Prieto Go´mez, PhD Student

  University of Alcalá

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)