Breast CancerNCT00877188
Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors
A study testing exercise in people with Breast Cancer and Exercise, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the effects of a combined aerobic and resistance exercise program in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Exercise, Physical Function
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Dec 2010
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage 0 to II breast cancer diagnosed within 5 years
- complete adjuvant therapy > 2 months, except hormone therapy
- > 18 years
Who cannot join
- disease in progress, recurrent, or metastasis
- medical or musculoskeletal condition which resistance exercise is contraindicated
- medication which may alter exercise response
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Graduate School of Physical Therapy, College of Medicine, NTU
Taipei
About this study
Official title: Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors: Upper Extremity Function, Quality of Life and Fitness Outcomes
The purpose of this study is to evaluate the effects of a combined aerobic and resistance exercise program in breast cancer survivors.
Read the detailed description
Cancer and cancer treatment side effects are associated with fatigue, pain, decreased cardiovascular fitness and muscle strength, and overall quality of life. Furthermore, cancer survivors are at increased risk for cancer recurrence and for secondary effect such as cardiovascular disease, diabetes, obesity, osteoporosis, and functional decline. Increase physical activity or exercise is proposed to overcome the negative psychological and physiological effects. Preliminary research evidence shows that exercise in cancer survivors improves quality of life, cardiorespiratory fitness, physical functioning, and decrease of fatigue. However, the best exercise mode and intensity has not been well established. Little is known regarding the long term effect. No study investigated impact of exercise for breast cancer survivors on upper extremity function, and correlation between fitness, upper extremity function and quality of life.
- Conditions
- Breast Cancer, Exercise, Physical Function
- Being tested
- exercise
- Keywords
- breast cancer, exercise, upper extremity function, quality of life
- 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.
exerciseOther
supervised combined aerobic and progressive resistance training for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | supervised combined aerobic and resistance training for 12 weeks Receives: Other: exercise |
| control | No intervention | waist list control with usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle fitness, quality of life, upper extremity function
Measured: baseline, 12 weeks post exercise training and follow up 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jau-Yih Tsauo, PHD, Study chair, Graduate School of Physical Therapy, College of Medicine, Nationall Taiwan University, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877188
- Sponsor's protocol ID
- 200808034R
- Other IDs
- NTUH98-M1178
- Status last verified
- Nov 2012
- First submitted
- 22 Mar 2009
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors: Upper Extremity Function, Quality of Life and Fitness Outcomes
- ClinicalTrials.gov ID
- NCT00877188
- Acronym / sponsor ID
- 200808034R
- Conditions
- Breast Cancer, Exercise, Physical Function
- Keywords
- breast cancer, exercise, upper extremity function, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Apr 2009 (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 effects of a combined aerobic and resistance exercise program in breast cancer survivors.
Detailed description
Cancer and cancer treatment side effects are associated with fatigue, pain, decreased cardiovascular fitness and muscle strength, and overall quality of life. Furthermore, cancer survivors are at increased risk for cancer recurrence and for secondary effect such as cardiovascular disease, diabetes, obesity, osteoporosis, and functional decline. Increase physical activity or exercise is proposed to overcome the negative psychological and physiological effects. Preliminary research evidence shows that exercise in cancer survivors improves quality of life, cardiorespiratory fitness, physical functioning, and decrease of fatigue. However, the best exercise mode and intensity has not been well established. Little is known regarding the long term effect. No study investigated impact of exercise for breast cancer survivors on upper extremity function, and correlation between fitness, upper extremity function and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: exercisesupervised combined aerobic and resistance training for 12 weeks |
| control | No intervention | –waist list control with usual care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stage 0 to II breast cancer diagnosed within 5 years
- complete adjuvant therapy > 2 months, except hormone therapy
- > 18 years
Key exclusion criteria (3 listed)
- disease in progress, recurrent, or metastasis
- medical or musculoskeletal condition which resistance exercise is contraindicated
- medication which may alter exercise response
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 |
|---|---|---|
| exercisesupervised combined aerobic and progressive resistance training for 12 weeks | Other | exercise |
Primary outcome
muscle fitness, quality of life, upper extremity function
Time frame: baseline, 12 weeks post exercise training and follow up 12 weeks
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 21 Dec 2012.
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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.
Jau-Yih Tsauo, PHD study chair
Graduate School of Physical Therapy, College of Medicine, Nationall Taiwan University, Taipei, Taiwan
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 in people with Breast Cancer and Exercise, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 21 Dec 2012. 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 Taiwan. 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?
muscle fitness, quality of life, upper extremity function (time frame: baseline, 12 weeks post exercise training and follow up 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2012.