Effect of Low vs Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors

NCT02982564 | Completed DMC

• 1 other identifier: 1SC3GM116684-01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of two exercise programs: 1) one program will be at low intensity; 2) the other program will be at moderate intensity. One hundred forty two women who are breast cancer survivors will be recruited. Participants will be educated on a home exercise program to be performed at either low or moderate intensity, according to group assignment. Evaluations to participants will consist of function and quality of life.

Conditions

Breast Neoplasms

Keywords

Exercise; Physical Functioning; Hispanic

Outcome Measures

Primary Outcomes (5)

• Change in Cardiovascular fitness: Six-minute walk test

  Will be used to assess physical function in cancer survivors. It has been validated to assess exercise tolerance (American Thoracic Society, 2002) and has been recommended as a test suitable for fitness, as it is highly correlated with oxygen uptake. An increase in walking distance indicates an improvement in performance. Data will be collected on distance walked (meters), number of rests, and duration of rest during the 6 minutes. Rating of perceived exertion will be monitored. Heart rate and oxygen saturation will be examined using a pulse oximeter.

  At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.

• Change in Quality of Life

  Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0/1.1 General Health. The Spanish version (Salud general) will be used. It contains two subdomains: Global Physical Health and Global Mental Health. The final score can be converted to a score for the EUROQoL.

  At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.

• Change in Functioning

  PROMIS Item Bank v. 1.2 Physical Function. The Spanish version (Capacidad de Funcionamiento Físico - Cuestionario Abreviado 20) will be used. It consists of 20 items, measuring upper extremity function, as well as gross motor function such as walking and stairs use.

  At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.

• Change in Depression

  Inventario -II de depresión de Beck (BDI-II). The Spanish version has proper psychometric properties for assessment of depression (internal consistency, obtaining a Cronbach alfa of 0.89 and has reported known-group validity; Vega-Dienstmaier, 2014).

  At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.

• Change in Body Image

  Body Appreciation Scale-2 (BAS-2; Tylka \& Wood-Barcalow, 2014), Spanish version will be used to measure body appreciation, an aspect that encompasses positive self-evaluation of body image. It has 13 items with responses ranging from 1 (never) to 5 (always). The Spanish BAS showed adequate internal consistency (Cronbach's α = .91) and construct validity (correlations with BMI, influence of the body shape model, perceived stress, coping strategies, self-esteem and variables from the Eating Disorders Inventory-2). Test-retest reliability ranged from .88 to .90.

  At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.

Secondary Outcomes (3)

• Change in Physical Activity

  At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.

• Change in Time spend in Habitual Physical Activities

  At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.

• Adherence

  At 6-month follow up.

Study Arms (2)

Low Intensity Exercise

EXPERIMENTAL

Participants engage in low intensity endurance exercise.

Behavioral: Exercise Program Low Intensity

Moderate Intensity Exercise

EXPERIMENTAL

Participants engage in moderate intensity endurance exercise.

Behavioral: Exercise Program Moderate Intensity

Interventions

Exercise Program Low Intensity BEHAVIORAL

This arm includes a low-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.

Low Intensity Exercise

Exercise Program Moderate Intensity BEHAVIORAL

This arm includes a moderate-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.

Moderate Intensity Exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fifty years of age or older
• Be a resident of the San Juan metropolitan area of Puerto Rico (PR)
• Diagnosed with breast cancer
• Be classified in breast cancer stage grouping 0 to III according to the American Joint Committee on Cancer Classification of Malignant Tumors (TNM) Staging System (2013)
• Have completed adjuvant curative therapy at least two months to 5 years prior to recruitment

You may not qualify if:

• Women who have contraindications to exercise, such as extreme fatigue or anemia, unstable cardiac disease; uncontrolled diabetes; uncontrolled hypertension; coagulopathies; inability to ambulate independently
• Women with metastasis or secondary cancers
• Women who already meet the national standard for exercise (≥ 150 minutes per week of moderate exercise).

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

Puerto Rico Clinical and Translational Research Consortium

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (1)

• Mulero Portela AL, Colon Santaella CL, Rogers LQ, Missaghian Vissepo M. Effect of low- and moderate-intensity endurance exercise on physical functioning among breast cancer survivors: a randomized controlled trial. Support Care Cancer. 2024 Dec 21;33(1):49. doi: 10.1007/s00520-024-09100-2.

  PMID: 39714637 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Ana L Mulero-Portela, PhD

  University of Puerto Rico Medical Sciences Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 5, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

PR (1)