- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02982564
Effect of Low vs Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors
June 15, 2023 updated by: University of Puerto Rico
Effect of Low-intensity Versus Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Improvements in early diagnosis and treatment for breast cancer in women have resulted in increased survivorship.
An unintended consequence of increased survival, however, is that more women are living with the negative sequelae associated with cancer treatment, including decreased physical function.
Exercise has been beneficial in arresting these sequelae, but adherence to exercise guidelines continues to be a challenge.
As most breast cancer survivors are middle-aged and older, an alternative to enhance exercise engagement and adherence might be providing a low intensity exercise program.
The overall purpose of this study is to assess the impact of a low intensity versus moderate intensity endurance exercise program on physical functioning on breast cancer survivors.
It is hypothesized that participants of the low intensity exercise program will demonstrate similar physical functioning as participants in the moderate intensity exercise program.
The Theory of Planned Behavior will serve as framework for the intervention.
A convenience sample of 142 women, residents of Puerto Rico, age 50 or older, with a diagnosis of breast cancer, stage 0 thru III, who have received surgical treatment for breast cancer, with or without adjuvant therapy, will be randomly assigned to a low intensity or moderate intensity endurance intervention.
Both interventions will be home-based, have a duration of 6 months, and be provided by physical therapists.
An evaluator blinded to group assignment will assess participants at baseline and at completion of the intervention.
Primary outcome measures will consist of physical functioning, and health-related quality of life.
Study Type
Interventional
Enrollment (Actual)
142
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ana L Mulero-Portela, PhD
- Phone Number: 3493;3483 787-758-2525
- Email: ana.mulero@upr.edu
Study Locations
-
-
-
San Juan, Puerto Rico, 00936-5067
- Puerto Rico Clinical and Translational Research Consortium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low Intensity Exercise
Participants engage in low intensity endurance exercise.
|
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.
|
Experimental: Moderate Intensity Exercise
Participants engage in moderate intensity endurance exercise.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cardiovascular fitness: Six-minute walk test
Time Frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
|
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
Time Frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
|
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
Time Frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
|
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
Time Frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
|
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
Time Frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Physical Activity
Time Frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
|
Accelerometers will be used to evaluate the amount of time spent in low to moderate and moderate to vigorous physical activity.
Accelerometry has been found to be a valid measure of physical activity, as compared to oxygen uptake and calorimetry (Hendelman et al., 2000; Kuffel, et al., 2011) and has been used nationally by the National Health and Nutritional Examination Survey (NHANES) study to document, more precisely than self-reported measures, the intensity and time of physical activity (Hawkins et al., 2009).
The procedures established by NHANES (CDC, 2005) will be followed.
|
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
Time Frame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
|
International Physical Activity Questionnaire (IPAQ, 2002, self-administered, long Spanish version).
The IPAQ assesses multiple domains of activity such as leisure, occupation, household, and transport, among others (Craig et al., 2003).
This questionnaire has proved to be reliable (Roman-Viñas et al., 2010), and has been validated with accelerometer, pedometer, physical activity log, and maximal oxygen uptake (van Poppel et al., 2010).
|
At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
|
Adherence
Time Frame: At 6-month follow up.
|
Exercise logs.
Participants will be asked to record week number and type and duration of exercise.
Logs will be collected at the 6-month evaluation session.
|
At 6-month follow up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ana L Mulero-Portela, PhD, University of Puerto Rico Medical Sciences Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
May 1, 2023
Study Completion (Actual)
May 1, 2023
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
November 30, 2016
First Posted (Estimated)
December 5, 2016
Study Record Updates
Last Update Posted (Estimated)
June 16, 2023
Last Update Submitted That Met QC Criteria
June 15, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1SC3GM116684-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be presented at the conclusion of the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Neoplasms
-
Emory UniversityEisai Inc.TerminatedBreast Cancer | Breast Neoplasms | Breast Tumors | Neoplasms, Breast | Cancer of the Breast | Tumors, BreastUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
-
Seagen Inc.CompletedTriple Negative Breast Neoplasms | Hormone Receptor Positive Breast Neoplasms | HER2 Positive Breast Neoplasms | HER2 Mutations Breast NeoplasmsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Celgene CorporationTerminatedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
-
Providence Health & ServicesBrooklyn ImmunoTherapeutics, LLCActive, not recruitingBreast Neoplasm | Triple Negative Breast Cancer | Breast Neoplasm, MaleUnited States
-
Joseph Baar, MD, PhDCompletedBreast Cancer | Stage I Breast Cancer | Inflammatory Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast CancerUnited States
-
Wake Forest University Health SciencesMerck Sharp & Dohme LLCCompletedMale Breast Cancer | Breast - FemaleUnited States
-
GlaxoSmithKlineCompletedMetastatic Breast Cancer | Neoplasms, BreastJapan
Clinical Trials on Exercise Program Low Intensity
-
Cairo UniversityKing Khalid UniversityNot yet recruitingChronic Nonspecific Low-back PainEgypt
-
Queen's UniversityRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
Universidade Federal do CearáCompletedDiabetes MellitusBrazil
-
Thomas AdamsUniversity of Texas at AustinNot yet recruiting
-
University of Alabama at BirminghamNational Heart, Lung, and Blood Institute (NHLBI)WithdrawnMyocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Coronary Disease
-
Kessler FoundationNational Cancer Institute (NCI); Kessler Institute for RehabilitationCompletedBreast CancerUnited States
-
University of AlbertaAlberta Diabetes InstituteCompletedExercise Intensity, Glycemic Control and Abdominal Fat in People With Type 2 Diabetes: A Pilot StudyType 2 Diabetes MellitusCanada
-
Hacettepe UniversityCompletedKnee Osteoarthritis | Pain, AcuteTurkey
-
Charles Drew University of Medicine and ScienceNational Center for Research Resources (NCRR)CompletedObesity | Metabolic Syndrome | Insulin ResistanceUnited States