Acute LeukemiaEQUALNCT02246907
Exercise and Quality of Life in Leukemia Patients
A study testing Exercise in people with Acute Leukemia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with acute leukemia by pathology report
- Admitted for induction chemotherapy within in the previous 96 hours or +/- 3 days from initiation of induction chemotherapy
- An expected hospital stay of 3-4 weeks or longer
- Participation in the study must be approved by the physician directly responsible for the patient's care while at University of North Carolina -Hospitals
- Age >21 years of age
- Willing and able to provide, signed informed consent
- Willing and able to use a computer to complete study questionnaires
- Ability to understand and speak English
Who cannot join
- The criteria below will be determined by the patient's physician and a review of the patient's medical history. If any of the exclusion criteria are observed, the patients will be informed and excluded from participating in the study.
- Participation in this study will involve the same risks as any exercise regimen. Given the potential risks involved, patients will be screened for exclusion based upon the following criteria:
- Cardiovascular disease (unless the disease would not compromise the patient's ability to participate in the exercise rehabilitation program)
- Acute or chronic respiratory disease that would compromise the patient's ability to participate in the exercise rehabilitation program
- Acute or chronic bone, joint, or muscular abnormalities that would compromise the patient's ability to participate in the exercise rehabilitation program
- Inability to understand and speak English
Show all 9Show fewer
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Another active malignancy
- Patients will also be excluded if they have active bleeding, acute thrombosis, ischemia, hemodynamically unstable, and uncontrolled pain.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Lineberger Comprehenisive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
Official title: Effects of Exercise on Patient Reported Outcomes in Newly Diagnosed Adults With Acute Leukemia During Induction Treatment: Exercise and Quality of Life in Leukemia Patients (EQUAL)
The purpose of this study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia patients.
Read the detailed description
The purpose of this randomized, prospective, longitudinal study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances outcomes among acute leukemia patients. The study will include 2 groups for a total sample size of 30: n=15 control group and n=15 intervention group. Each patient enrolled in the intervention arm will participate in an exercise program for the duration of their hospitalization, 4-6 weeks on average during the first treatment (induction chemotherapy).
- Conditions
- Acute Leukemia
- Being tested
- Exercise
- Keywords
- Health related quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Exercise and Quality of Life in Acute Leukemia Patients
All intervention patients will participate in an individualized prescriptive exercise intervention 2 to 4 times per week for a period of the induction chemotherapy/in-hospital recovery. The exercise intervention will begin on week 1 of the study, the day after the first batteries of initial assessments are concluded. Each exercise session will be divided into two parts. One part will be administered in the morning and the second one late in the afternoon. There will be a period of rest of at least 36 hours between each exercise session.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will receive standard of care which includes recreational therapy and standard encouragement. |
| Exercise | Other | Participants in this arm will receive standard of care plus exercise for the duration of their inpatient stay for induction chemotherapy. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare symptoms of fatigue in newly diagnosed acute leukemia patients
Symptoms will be assessed by patient reported survey at baseline, weekly through patient hospitalization, and then again at patient's first appointment after hospital discharge. We are interested in how the symptom changes over time.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary outcomes (9)
Evaluate health-related quality of life changes over time
Health related quality of life will be assessed by patient reported survey at baseline, and at the week 4 timepoint. We are interested in change over time between groups
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Compare symptoms of anxiety between groups
Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Compare symptoms of depression between groups
Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Compare sleep quality between groups
Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in cardiovascular function
Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in muscle strength
Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in body composition
Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in functional mobility
Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in muscle size
Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Bryant, PhD, RN, Principal investigator, UNC- Chapel HillClaudio Battaglini, PhD, Principal investigator, UNC- Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246907
- Sponsor's protocol ID
- LCCC1234
- Acronym
- EQUAL
- Status last verified
- Nov 2016
- First submitted
- 27 Mar 2014
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Patient Reported Outcomes in Newly Diagnosed Adults With Acute Leukemia During Induction Treatment: Exercise and Quality of Life in Leukemia Patients (EQUAL)
- ClinicalTrials.gov ID
- NCT02246907
- Acronym / sponsor ID
- EQUAL / LCCC1234
- Conditions
- Acute Leukemia
- Keywords
- Health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Sep 2014 (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 impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia patients.
Detailed description
The purpose of this randomized, prospective, longitudinal study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances outcomes among acute leukemia patients. The study will include 2 groups for a total sample size of 30: n=15 control group and n=15 intervention group. Each patient enrolled in the intervention arm will participate in an exercise program for the duration of their hospitalization, 4-6 weeks on average during the first treatment (induction chemotherapy).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive standard of care which includes recreational therapy and standard encouragement. |
| Exercise | Other | Other: ExerciseParticipants in this arm will receive standard of care plus exercise for the duration of their inpatient stay for induction chemotherapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly diagnosed with acute leukemia by pathology report
- Admitted for induction chemotherapy within in the previous 96 hours or +/- 3 days from initiation of induction chemotherapy
- An expected hospital stay of 3-4 weeks or longer
- Participation in the study must be approved by the physician directly responsible for the patient's care while at University of North Carolina -Hospitals
- Age >21 years of age
Key exclusion criteria (9 listed)
- The criteria below will be determined by the patient's physician and a review of the patient's medical history. If any of the exclusion criteria are observed, the patients will be informed and excluded from participating in the study.
- Participation in this study will involve the same risks as any exercise regimen. Given the potential risks involved, patients will be screened for exclusion based upon the following criteria:
- Cardiovascular disease (unless the disease would not compromise the patient's ability to participate in the exercise rehabilitation program)
- Acute or chronic respiratory disease that would compromise the patient's ability to participate in the exercise rehabilitation program
- Acute or chronic bone, joint, or muscular abnormalities that would compromise the patient's ability to participate in the exercise rehabilitation program
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 |
|---|---|---|
| ExerciseAlso: Exercise and Quality of Life in Acute Leukemia PatientsAll intervention patients will participate in an individualized prescriptive exercise intervention 2 to 4 times per week for a period of the induction chemotherapy/in-hospital recovery. The exercise intervention will begin on week 1 of the study, the day after the first batteries of initial assessments are concluded. Each exercise session will be divided into two parts. One part will be administered in the morning and the second one late in the afternoon. There will be a period of rest of at least 36 hours between each exercise session. | Other | Exercise |
Primary outcome
Compare symptoms of fatigue in newly diagnosed acute leukemia patients
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Symptoms will be assessed by patient reported survey at baseline, weekly through patient hospitalization, and then again at patient's first appointment after hospital discharge. We are interested in how the symptom changes over time.
9 secondary outcomes
Evaluate health-related quality of life changes over time
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Compare symptoms of anxiety between groups
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Compare symptoms of depression between groups
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Compare sleep quality between groups
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in cardiovascular function
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in muscle strength
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in body composition
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in functional mobility
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Changes in muscle size
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 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 23 Nov 2016.
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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.
Ashley Bryant, PhD, RN principal investigator
UNC- Chapel Hill
Claudio Battaglini, PhD principal investigator
UNC- Chapel Hill
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 Acute Leukemia, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 8 inclusion and 9 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 23 Nov 2016. 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 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?
Compare symptoms of fatigue in newly diagnosed acute leukemia patients (time frame: participants will be followed for the duration of hospital stay, an expected average of 6 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 23 Nov 2016.