Clinical trial NCT02982564: Effect of Low vs Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors
Official title: Effect of Low-intensity Versus Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Exercise
Physical Functioning
Hispanic
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 142
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Fifty years of age or older
2. Be a resident of the San Juan metropolitan area of Puerto Rico (PR)
3. Diagnosed with breast cancer
4. 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)
5. Have completed adjuvant curative therapy at least two months to 5 years prior to recruitment

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Cardiovascular fitness: Six-minute walk test
timeFrame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
measure: Change in Quality of Life
timeFrame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
measure: Change in Functioning
timeFrame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
measure: Change in Depression
timeFrame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
measure: Change in Body Image
timeFrame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
Secondary outcomes:
measure: Change in Physical Activity
timeFrame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
measure: Change in Time spend in Habitual Physical Activities
timeFrame: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
measure: Adherence
timeFrame: At 6-month follow up.
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Puerto Rico Clinical and Translational Research Consortium
Study officials:
affiliation: University of Puerto Rico Medical Sciences Campus
name: Ana L Mulero-Portela, PhD
role: PRINCIPAL_INVESTIGATOR
References: