Breast NeoplasmsNCT02982564
Effect of Low vs Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors
A study testing Exercise Program Low Intensity and Exercise Program Moderate Intensity in people with Breast Neoplasms, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Exercise Program Low Intensity and Exercise Program Moderate Intensity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 1 Mar 2016to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Puerto Rico Clinical and Translational Research Consortium
San Juan, 00936-5067
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Exercise Program Low Intensity, Exercise Program Moderate Intensity
- Keywords
- Exercise, Physical Functioning, Hispanic
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Program Low IntensityBehavioural
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.
Exercise Program Moderate IntensityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Exercise | Experimental | Participants engage in low intensity endurance exercise. Receives: Behavioral: Exercise Program Low Intensity |
| Moderate Intensity Exercise | Experimental | Participants engage in moderate intensity endurance exercise. Receives: Behavioral: Exercise Program Moderate Intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
Secondary outcomes (3)
Change in Physical Activity
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.
Measured: 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
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).
Measured: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
Adherence
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.
Measured: At 6-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 Mar 2016
- Primary completionMay 2023
- Study completionMay 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana L Mulero-Portela, PhD, Principal investigator, University of Puerto Rico Medical Sciences Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982564
- Sponsor's protocol ID
- 1SC3GM116684-01
- Status last verified
- Jun 2023
- First submitted
- 23 Nov 2016
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be presented at the conclusion of the study.
Publications
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.
PubMed 39714637
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-intensity Versus Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02982564
- Acronym / sponsor ID
- 1SC3GM116684-01
- Conditions
- Breast Neoplasms
- Keywords
- Exercise, Physical Functioning, Hispanic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- May 2023 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Exercise | Experimental | Behavioral: Exercise Program Low IntensityParticipants engage in low intensity endurance exercise. |
| Moderate Intensity Exercise | Experimental | Behavioral: Exercise Program Moderate IntensityParticipants engage in moderate intensity endurance exercise. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Program Low IntensityThis 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. | Behavioural | Low Intensity Exercise |
| Exercise Program Moderate IntensityThis 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. | Behavioural | Moderate Intensity Exercise |
Primary outcome
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.
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.
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.
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).
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.
3 secondary outcomes
Change in Physical Activity
Time frame: 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.
Adherence
Time frame: At 6-month follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 39714637Mulero 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.
- Individual participant dataSharing planned: Yes. Data will be presented at the conclusion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana L Mulero-Portela, PhD principal investigator
University of Puerto Rico Medical Sciences Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program Low Intensity and Exercise Program Moderate Intensity in people with Breast Neoplasms, run by University of Puerto Rico at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.