Breast CancerNCT01709175
Strength Training Study for Survivors of Breast and Gynecologic Cancer
A study testing Strength Training in people with Breast Cancer and Gynecologic Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The purpose of this study is to compare once-a-week vs. twice-a-week strength training in survivors of breast and gynecologic cancer to determine which is the optimal exercise prescription. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer, Ovarian Cancer
- What is being tested?
- Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Jan 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Survivor of Breast or Gynecologic Cancer
- Completed Primary Treatment (hormone treatments are ok)
- 18 years of age or older
- Physician's Permission to Participate
Who cannot join
- High Risk Individuals (determined by questionnaire)
- Secondary Health Problems that could increase the risk of participating (Includes but not limited to: Uncontrolled angina/hypertension, heart failure, osteoporosis, brain metastases, history of seizures).
- Report participating in a strength training program in the past six (6) months
- Have had a change in medication in the past 30 days
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Lab: Queen Elizabeth II Dickson Centre
Halifax, Nova Scotia
About this study
Official title: The Effect of Resistance Exercise Frequency in Breast and Gynecologic Cancer Survivors
The purpose of this study is to compare once-a-week vs. twice-a-week strength training in survivors of breast and gynecologic cancer to determine which is the optimal exercise prescription.
Read the detailed description
As a result of cancer and its treatment, survivors of breast and gynecologic cancer are reported to have deficits in both physical and psycho-social health. In cancer survivors exercise has been shown to improve fitness, increase bone density and lean body mass, enhance self-esteem, and reduce fatigue. These changes have a positive effect on the survivor's physical functioning and quality of life. However, there are few studies which have examined the effects of strength training or studies aimed at determining optimal exercise prescription in this population. Therefore, the purpose of this study is to compare two strength training prescriptions (once-a-week vs. twice-a-week strength training) to determine which prescription (if any) results in greater benefit for survivors. It is hoped that the results of this study will lead to a better understanding of how strength training improves the health of survivors and will help inform future exercise guidelines for this population.
- Being tested
- Strength Training
- Keywords
- Cancer, Breast Cancer, Gynecologic Cancer, Strength Training, Exercise, Physical Activity, Fatigue, Quality of Life, Strength, Fitness, Cancer Survivor, Survivor
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Uterine Cervical Neoplasms, Neoplasms, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength TrainingBehavioural
Also called Resistance Exercise, Weight Training, Body Building, Exercise
This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.
| Study group | Role | What they receive |
|---|---|---|
| Once-a-week Strength Training | Experimental | After completing the introduction to strength training (two sessions in the first week), participants randomized to the once-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet ONCE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises. Receives: Behavioral: Strength Training |
| Twice-a-week Strength Training | Experimental | After completing the introduction to strength training (two sessions in the first week), participants randomized to the twice-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet TWICE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises. Receives: Behavioral: Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Muscular Strength
Muscular Strength will be assessed using the predicted one-repetition maximum method (Brzycki method)using the bench press and leg press to measure upper and lower body strength.
Measured: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Secondary outcomes (6)
Process Measures
Process measures will provide insight about the feasibility of the exercise prescriptions. Included measures are: recruitment (percent of interested survivors who consent); adherence (the number of sessions attended); compliance (the degree to which the survivors follow the exercise prescription); and safety (all adverse events will be recorded)
Measured: Final (end of week 13)
Changes in Muscular Endurance
Muscular Endurance will be assessed using the standard load test. Participants will lift a weight equal to 50% one repetition maximum as many times as possible. The bench press and leg press will be used to measure endurance of the upper and lower body.
Measured: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Body Composition
Body composition will be assessed using bioelectric impedance to determine percent body fat, lean body mass, and fat mass.
Measured: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Quality of Life
Quality of Life will be assessed using the Medical Outcomes Survey - Short Form. This survey measures multiple aspects of quality of life including: physical function, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, and mental health.
Measured: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Fatigue
Fatigue will me measured using the Fatigue scale of the Functional Assessment of Cancer Treatment. This is a 13 item questionnaire that measures the degree to which a cancer survivor experiences fatigue
Measured: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Physical Activity Levels
Physical activity will be estimated using the Godin Leisure Time Exercise Questionnaire.
Measured: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2015
- Study completionJan 2015
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 Nova Scotia Health AuthorityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Scott Grandy, Nova Scotia Health Authority
- Investigators
- Scott Grandy, Ph D, Principal investigator, CDHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709175
- Sponsor's protocol ID
- JB-007
- Status last verified
- Jun 2015
- First submitted
- 9 Oct 2012
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistance Exercise Frequency in Breast and Gynecologic Cancer Survivors
- ClinicalTrials.gov ID
- NCT01709175
- Acronym / sponsor ID
- JB-007
- Keywords
- Cancer, Breast Cancer, Gynecologic Cancer, Strength Training, Exercise, Physical Activity, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- Nov 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Oct 2012 (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 compare once-a-week vs. twice-a-week strength training in survivors of breast and gynecologic cancer to determine which is the optimal exercise prescription.
Detailed description
As a result of cancer and its treatment, survivors of breast and gynecologic cancer are reported to have deficits in both physical and psycho-social health. In cancer survivors exercise has been shown to improve fitness, increase bone density and lean body mass, enhance self-esteem, and reduce fatigue. These changes have a positive effect on the survivor's physical functioning and quality of life. However, there are few studies which have examined the effects of strength training or studies aimed at determining optimal exercise prescription in this population. Therefore, the purpose of this study is to compare two strength training prescriptions (once-a-week vs. twice-a-week strength training) to determine which prescription (if any) results in greater benefit for survivors. It is hoped that the results of this study will lead to a better understanding of how strength training improves the health of survivors and will help inform future exercise guidelines for this population.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once-a-week Strength Training | Experimental | Behavioral: Strength TrainingAfter completing the introduction to strength training (two sessions in the first week), participants randomized to the once-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet ONCE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises. |
| Twice-a-week Strength Training | Experimental | Behavioral: Strength TrainingAfter completing the introduction to strength training (two sessions in the first week), participants randomized to the twice-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet TWICE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female Survivor of Breast or Gynecologic Cancer
- Completed Primary Treatment (hormone treatments are ok)
- 18 years of age or older
- Physician's Permission to Participate
Key exclusion criteria (4 listed)
- High Risk Individuals (determined by questionnaire)
- Secondary Health Problems that could increase the risk of participating (Includes but not limited to: Uncontrolled angina/hypertension, heart failure, osteoporosis, brain metastases, history of seizures).
- Report participating in a strength training program in the past six (6) months
- Have had a change in medication in the past 30 days
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 |
|---|---|---|
| Strength TrainingAlso: Resistance Exercise, Weight Training, Body Building, ExerciseThis is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting. | Behavioural | Once-a-week Strength Training, Twice-a-week Strength Training |
Primary outcome
Changes in Muscular Strength
Time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Muscular Strength will be assessed using the predicted one-repetition maximum method (Brzycki method)using the bench press and leg press to measure upper and lower body strength.
6 secondary outcomes
Process Measures
Time frame: Final (end of week 13)
Changes in Muscular Endurance
Time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Body Composition
Time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Quality of Life
Time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Fatigue
Time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Physical Activity Levels
Time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
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 8 Jun 2015.
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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.
Scott Grandy, Ph D principal investigator
CDHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training in people with Breast Cancer and Gynecologic Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
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 4 inclusion and 4 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 8 Jun 2015. 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 Canada. 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?
Changes in Muscular Strength (time frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)). 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 8 Jun 2015.