Breast CancerNCT02844504
Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness
A study testing Low Intensity Exercise Training 1 and Low Intensity Exercise Training 2 in people with Breast Cancer, run by Kessler Foundation at 2 sites in United States.
Trial summary
Breast cancer patients often suffer from long-term physical symptoms of weakness. In this study, investigators propose to compare how two different low intensity physical exercise training programs can improve handgrip strength for breast cancer patients with symptoms of weakness. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Low Intensity Exercise Training 1 and Low Intensity Exercise Training 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to Sep 2020
- 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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female aged 40-75 yrs
- Right handed, as determined by the Edinburgh Inventory (Oldfield, 1971)
- Proficient in English
- Must be available for the familiarization, and testing sessions
Who cannot join
- Symptoms for mild or severe depression as determined by a Patient Health Questionnaire (PHQ-8) score >14
- Significant cognitive impairments as defined by a score <28 in the Folstein Mini-Mental Screening Examination (MMSE, Folstein et al .1975).
- Participated in any type of motor imagery or strength training program in the last 5 years, or plan to start any motor imagery or physical strength training program for the 3 months duration of the study
- Neurological, psychiatric, musculoskeletal or other types of disorder that may affect participants sensorimotor function and cognitive abilities
- Current medication believed to affect cognitive/psychomotor function (i.e., opioid, analgesics, anxiolytics or antidepressants)
- History of alcohol, smoking, and drug abuse
- Any contraindication for MRI
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kessler Foundation
West Orange, New Jersey, 07052
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Breast cancer patients often suffer from long-term physical symptoms of weakness. In this study, investigators propose to compare how two different low intensity physical exercise training programs can improve handgrip strength for breast cancer patients with symptoms of weakness. Using brain imaging, the study will also investigate changes in brain structure, and muscle activity associated with handgrip.
Read the detailed description
Participants will be randomized to either a no treatment group or one of two low intensity 6-week exercise training. Outcomes will be measured at baseline, post-intervention and 4 weeks post intervention.
- Conditions
- Breast Cancer
- Being tested
- Low Intensity Exercise Training 1, Low Intensity Exercise Training 2
- Keywords
- Fatigue, Breast cancer, Force, Motor imagery, Cancer Treatment
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Exercise Training 1Behavioural
Subjects will perform handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded)
Low Intensity Exercise Training 2Behavioural
Subjects will perform a different handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded)
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Exercise Training 1 | Experimental | Cancer survivors will receive low intensity handgrip exercise training. Receives: Behavioral: Low Intensity Exercise Training 1 |
| Low Intensity Exercise Training 2 | Experimental | Cancer survivors will receive low intensity handgrip exercise training different than other arm. Receives: Behavioral: Low Intensity Exercise Training 2 |
| Control | No intervention | This group will receive no training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip force
Primary outcome will be used to compare pre to post change in maximum force contraction at the end of the 6-week intervention between groups.Similar comparison will be done between retention test (4 weeks after training) and posttest (immediately after training).
Measured: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Secondary outcomes (7)
Pre to Post changes of functional brain to muscle coupling at maximum handgrip contraction
Functional brain to muscle coupling will be measured by computing the EMG-EEG coherence before training, after training, and 4 weeks after end of intervention. Values will be compared between groups.
Measured: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Pre to Post changes in EMG amplitude at maximum handgrip contraction
EMG of the right arm muscles will be assessed during maximum handgrip contraction before training, after training, and 4 weeks after end of intervention. Values will be compared between groups.
Measured: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Pre to Post changes in Brain activity during maximum handgrip contraction
functional magnetic resonance imaging will used to measure brain activity when subject performs maximum muscle handgrip contraction before training, after training. Values will be compared between groups.
Measured: Pretest (before training), Posttest (immediately after end of training)
Functional brain to muscle (EEG-EMG) phase coupling at low intensity handgrip muscle contraction.
Corticomuscular coherence between EEG signal from contralateral motor region and EMG signal from handgrip muscles will be computed while subjects perform handgrip contraction at 20% of their maximum force.Group x Time interaction will be measured.
Measured: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
EEG Brain connectivity during low intensity handgrip muscle contraction
functional connectivity within the brain networks will be studied while subjects perform 20% of their maximum handgrip contraction. Group x Time interaction will be measured.
Measured: Pretest (before training), Posttest (immediately after end of training)
Fatigue sustained handgrip contraction task duration
Subjects will perform a sustained handgrip contraction task at 20% maximal force.The task duration (a measure of endurance) will be measured for each subject in the three groups, before and after training, and after 4 weeks of end of intervention. Group x Time interaction will be measured.
Measured: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
functional brain to muscle coupling during fatigue
EMG-EEG coherence will be studied when subjects get fatigue after performing a sustained muscle contraction task at 20% maximal force. Group x Time interaction will be measured.
Measured: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2020
- Study completionSep 2020
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 Kessler FoundationThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Kessler Institute for Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Guang Yue, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844504
- Sponsor's protocol ID
- R-849-14
- Other IDs
- 5R01CA189665-02
- Status last verified
- Oct 2020
- First submitted
- 23 Jun 2016
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness
- ClinicalTrials.gov ID
- NCT02844504
- Acronym / sponsor ID
- R-849-14
- Conditions
- Breast Cancer
- Keywords
- Fatigue, Breast cancer, Force, Motor imagery, Cancer Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Kessler Institute for Rehabilitation
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 26 Jul 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.
Breast cancer patients often suffer from long-term physical symptoms of weakness. In this study, investigators propose to compare how two different low intensity physical exercise training programs can improve handgrip strength for breast cancer patients with symptoms of weakness. Using brain imaging, the study will also investigate changes in brain structure, and muscle activity associated with handgrip.
Detailed description
Participants will be randomized to either a no treatment group or one of two low intensity 6-week exercise training. Outcomes will be measured at baseline, post-intervention and 4 weeks post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Exercise Training 1 | Experimental | Behavioral: Low Intensity Exercise Training 1Cancer survivors will receive low intensity handgrip exercise training. |
| Low Intensity Exercise Training 2 | Experimental | Behavioral: Low Intensity Exercise Training 2Cancer survivors will receive low intensity handgrip exercise training different than other arm. |
| Control | No intervention | –This group will receive no training. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female aged 40-75 yrs
- Right handed, as determined by the Edinburgh Inventory (Oldfield, 1971)
- Proficient in English
- Must be available for the familiarization, and testing sessions
Key exclusion criteria (7 listed)
- Symptoms for mild or severe depression as determined by a Patient Health Questionnaire (PHQ-8) score >14
- Significant cognitive impairments as defined by a score <28 in the Folstein Mini-Mental Screening Examination (MMSE, Folstein et al .1975).
- Participated in any type of motor imagery or strength training program in the last 5 years, or plan to start any motor imagery or physical strength training program for the 3 months duration of the study
- Neurological, psychiatric, musculoskeletal or other types of disorder that may affect participants sensorimotor function and cognitive abilities
- Current medication believed to affect cognitive/psychomotor function (i.e., opioid, analgesics, anxiolytics or antidepressants)
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 |
|---|---|---|
| Low Intensity Exercise Training 1Subjects will perform handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded) | Behavioural | Low Intensity Exercise Training 1 |
| Low Intensity Exercise Training 2Subjects will perform a different handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded) | Behavioural | Low Intensity Exercise Training 2 |
Primary outcome
Hand grip force
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Primary outcome will be used to compare pre to post change in maximum force contraction at the end of the 6-week intervention between groups.Similar comparison will be done between retention test (4 weeks after training) and posttest (immediately after training).
7 secondary outcomes
Pre to Post changes of functional brain to muscle coupling at maximum handgrip contraction
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Pre to Post changes in EMG amplitude at maximum handgrip contraction
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Pre to Post changes in Brain activity during maximum handgrip contraction
Time frame: Pretest (before training), Posttest (immediately after end of training)
Functional brain to muscle (EEG-EMG) phase coupling at low intensity handgrip muscle contraction.
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
EEG Brain connectivity during low intensity handgrip muscle contraction
Time frame: Pretest (before training), Posttest (immediately after end of training)
Fatigue sustained handgrip contraction task duration
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
functional brain to muscle coupling during fatigue
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
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 5 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Guang Yue, PhD principal investigator
Kessler Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Exercise Training 1 and Low Intensity Exercise Training 2 in people with Breast Cancer, run by Kessler Foundation at 2 sites in United States.
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 7 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 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Hand grip force (time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)). 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 5 Oct 2020.