Aerobic Exercise, Resistance Exercise, or Flexibility and Relaxation Training in Inactive Older Female Breast Cancer Survivors
This study is ongoing, but not recruiting participants.
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00662103
First received: April 18, 2008
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
RATIONALE: Aerobic exercise, resistance exercise, and flexibility and relaxation training may reduce fatigue and improve the health and quality of life of breast cancer survivors. It is not yet known which type of exercise is more effective for inactive older female breast cancer survivors.
PURPOSE: This randomized clinical trial is studying aerobic exercise to see how well it works compared with resistance exercise or flexibility and relaxation training in improving the health and quality of life of inactive older female breast cancer survivors.
| Condition | Intervention |
|---|---|
|
Breast Cancer Cancer Survivor Fatigue Long-term Effects Secondary to Cancer Therapy in Adults Psychosocial Effects of Cancer and Its Treatment |
Behavioral: exercise intervention Other: laboratory biomarker analysis Other: questionnaire administration Other: survey administration Procedure: assessment of therapy complications Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: psychosocial assessment and care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Comparison of Aerobic and Resistance Exercise in Older Breast Cancer Survivors |
Resource links provided by NLM:
Further study details as provided by OHSU Knight Cancer Institute:
Primary Outcome Measures:
- Comparison of the effects of aerobic exercise vs flexibility and relaxation training (control) on fatigue, aerobic capacity, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months [ Time Frame: baseline,3 ,6 ,12, and 18 months ] [ Designated as safety issue: No ]
- Comparison of the effects of resistance exercise vs flexibility and relaxation training (control) on fatigue, muscle strength, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months [ Time Frame: baseline, 3 , 6 ,12, and 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Comparison of the relative effects of aerobic exercise vs resistance exercise on fatigue, physical functioning, physical health, and mental health as measured at baseline and at 3, 6, 12, and 18 months [ Time Frame: baseline, 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
- Determination of the mediating effects of fatigue and fitness on the relationship between exercise and physical functioning as measured at baseline and at 3, 6, 12, and 18 months [ Time Frame: baseline, 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
- Comparison of the individual and relative effects of aerobic exercise vs resistance exercise vs flexibility and relaxation training (control) on body composition and on biomarkers of cancer recurrence as measured at baseline and at 3, 6, 12, and 18 ... [ Time Frame: baseline, 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 141 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: progressive, aerobic exercise program
Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months.
|
Behavioral: exercise intervention
Arm I (progressive, aerobic exercise program): Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months. Arm II (progressive, resistance exercise program): Patients undergo resistance exercise training 3 days a week for 18 months. All biomarkers will be measured from urine, blood and plasma obtained from participants by the OHSU General Clinical Research Center (GCRC). Upon exit from the study we will confirm the presence/absence of metastatic disease, via verbal verification by the subject, in order to ensure that biomarkers were primarily reflective of bone turnover changes and not to metastases.
Other: questionnaire administration
Patients complete questionnaires at baseline and periodically during the study to assess demographic (i.e., age, income) and disease-specific (i.e., stage, treatment) variables, self-report mental and physical function, presence of chronic medical conditions, symptoms, fatigue, exercise outside the study exercise intervention, dietary intake, and psychosocial function.
Other: survey administration
Administered at measured at baseline, 3, 6, 12, and 18 months
Procedure: assessment of therapy complications
Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months )
Procedure: fatigue assessment and management
The Schwartz Cancer Fatigue (SCF) scale, a 6-item scale that specifically assesses the level of subjective fatigue that the participant is currently experiencing. The SCF has been used to measure fatigue in previous exercise studies. The Piper Fatigue Scale (PFS) consists of 22 items and four subscales: behavioral/severity, affective meaning, sensory and cognitive/mood. The scale has been shown to detect reductions in fatigue in cancer patients undergoing behavioral interventions to reduce fatigue, including exercise. Responses are averaged for subscale and total scores with higher scores indicating more fatigue. The PFS has been used to measure fatigue in previous studies of illness and/or medical treatments. 15 minute survey
Procedure: management of therapy complications
An interim safety/efficacy review will occur after the first half of enrolled participants completes their 3 month testing appointment (or after 3 months of exercise). The interim safety review will be overseen by OHSU NCI-designated Cancer Institute, while the efficacy review will be conducted by an independent monitor, Dr. George Knafl, a biostatistician in the OHSU School of Nursing, who is not a member of the study personnel.
Procedure: psychosocial assessment and care
We will include a 6-item measure of self-efficacy for exercise that has been validated in adults (Nigg, 2002) and has been used by Dr. Bennett (Co-I) in current work in cancer survivors. 5 min. survey
|
|
Active Comparator: progressive, resistance exercise program
Patients undergo resistance exercise training 3 days a week for 18 months.
|
Behavioral: exercise intervention
Arm I (progressive, aerobic exercise program): Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months. Arm II (progressive, resistance exercise program): Patients undergo resistance exercise training 3 days a week for 18 months. All biomarkers will be measured from urine, blood and plasma obtained from participants by the OHSU General Clinical Research Center (GCRC). Upon exit from the study we will confirm the presence/absence of metastatic disease, via verbal verification by the subject, in order to ensure that biomarkers were primarily reflective of bone turnover changes and not to metastases.
Other: questionnaire administration
Patients complete questionnaires at baseline and periodically during the study to assess demographic (i.e., age, income) and disease-specific (i.e., stage, treatment) variables, self-report mental and physical function, presence of chronic medical conditions, symptoms, fatigue, exercise outside the study exercise intervention, dietary intake, and psychosocial function.
Other: survey administration
Administered at measured at baseline, 3, 6, 12, and 18 months
Procedure: assessment of therapy complications
Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months )
Procedure: fatigue assessment and management
The Schwartz Cancer Fatigue (SCF) scale, a 6-item scale that specifically assesses the level of subjective fatigue that the participant is currently experiencing. The SCF has been used to measure fatigue in previous exercise studies. The Piper Fatigue Scale (PFS) consists of 22 items and four subscales: behavioral/severity, affective meaning, sensory and cognitive/mood. The scale has been shown to detect reductions in fatigue in cancer patients undergoing behavioral interventions to reduce fatigue, including exercise. Responses are averaged for subscale and total scores with higher scores indicating more fatigue. The PFS has been used to measure fatigue in previous studies of illness and/or medical treatments. 15 minute survey
Procedure: management of therapy complications
An interim safety/efficacy review will occur after the first half of enrolled participants completes their 3 month testing appointment (or after 3 months of exercise). The interim safety review will be overseen by OHSU NCI-designated Cancer Institute, while the efficacy review will be conducted by an independent monitor, Dr. George Knafl, a biostatistician in the OHSU School of Nursing, who is not a member of the study personnel.
Procedure: psychosocial assessment and care
We will include a 6-item measure of self-efficacy for exercise that has been validated in adults (Nigg, 2002) and has been used by Dr. Bennett (Co-I) in current work in cancer survivors. 5 min. survey
|
|
Active Comparator: flexibility and relaxation training [control]
Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months.
|
Other: laboratory biomarker analysis
All biomarkers will be measured from urine, blood and plasma obtained from participants by the OHSU General Clinical Research Center (GCRC). Upon exit from the study we will confirm the presence/absence of metastatic disease, via verbal verification by the subject, in order to ensure that biomarkers were primarily reflective of bone turnover changes and not to metastases.
Other: questionnaire administration
Patients complete questionnaires at baseline and periodically during the study to assess demographic (i.e., age, income) and disease-specific (i.e., stage, treatment) variables, self-report mental and physical function, presence of chronic medical conditions, symptoms, fatigue, exercise outside the study exercise intervention, dietary intake, and psychosocial function.
Other: survey administration
Administered at measured at baseline, 3, 6, 12, and 18 months
Procedure: assessment of therapy complications
Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months )
Procedure: fatigue assessment and management
The Schwartz Cancer Fatigue (SCF) scale, a 6-item scale that specifically assesses the level of subjective fatigue that the participant is currently experiencing. The SCF has been used to measure fatigue in previous exercise studies. The Piper Fatigue Scale (PFS) consists of 22 items and four subscales: behavioral/severity, affective meaning, sensory and cognitive/mood. The scale has been shown to detect reductions in fatigue in cancer patients undergoing behavioral interventions to reduce fatigue, including exercise. Responses are averaged for subscale and total scores with higher scores indicating more fatigue. The PFS has been used to measure fatigue in previous studies of illness and/or medical treatments. 15 minute survey
Procedure: management of therapy complications
An interim safety/efficacy review will occur after the first half of enrolled participants completes their 3 month testing appointment (or after 3 months of exercise). The interim safety review will be overseen by OHSU NCI-designated Cancer Institute, while the efficacy review will be conducted by an independent monitor, Dr. George Knafl, a biostatistician in the OHSU School of Nursing, who is not a member of the study personnel.
Procedure: psychosocial assessment and care
We will include a 6-item measure of self-efficacy for exercise that has been validated in adults (Nigg, 2002) and has been used by Dr. Bennett (Co-I) in current work in cancer survivors. 5 min. survey
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
- Stage 0-III disease
- Completed chemotherapy or radiotherapy > 2 years ago
- Is not a regular participant in moderate aerobic exercise (i.e., jogging, swimming) or moderate resistance exercise (> 3 times/week for ≥ 30 minutes/session) OR in vigorous aerobic or resistance exercise (> 3 times/week for ≥ 20 minutes/session)
- No stage IV breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Has obtained medical clearance to participate in study exercise programs
- No cognitive difficulties that would preclude answering the survey questions, participating in the performance tests, or giving informed consent
- No medical condition or movement or neurological disorder that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent medication that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator
- Concurrent hormonal therapy (e.g., selective estrogen receptor modulator [SERM] or aromatase inhibitor) for breast cancer allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662103
Locations
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Principal Investigator: | Kerri Winters-Stone, PhD | OHSU Knight Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00662103 History of Changes |
| Obsolete Identifiers: | NCT00665080 |
| Other Study ID Numbers: | CDR0000593410, R01CA120123, P30CA069533, OHSU-CR00005268, OHSU-IRB00003316 |
| Study First Received: | April 18, 2008 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by OHSU Knight Cancer Institute:
|
fatigue long-term effects secondary to cancer therapy in adults psychosocial effects of cancer and its treatment cancer survivor stage IA breast cancer stage IB breast cancer |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer breast cancer in situ |
Additional relevant MeSH terms:
|
Breast Neoplasms Fatigue Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013