LeukemiaNCT00502749
Exercise Program for Adolescents and Young Adults With Cancer
A study testing Exercise program and Questionnaires in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This pilot study will examine the safety, feasibility, and effect on quality of life of moderate physical activity on adolescent and young adult patients who are admitted to the hospital periodically for routine chemotherapy. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- What is being tested?
- Exercise program and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Oct 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents and young adults with leukemia/lymphoma between the ages of 12 and 25 years old.
- Leukemia/lymphoma patients admitted for chemotherapy with an anticipated hospital stay of at least three days.
Who cannot join
- 1. Patients with an underlying condition that precludes moderate exercise due to safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Safety, and Effect of an Exercise Program for Adolescents and Young Adults With Cancer
This pilot study will examine the safety, feasibility, and effect on quality of life of moderate physical activity on adolescent and young adult patients who are admitted to the hospital periodically for routine chemotherapy. Patients will be asked to participate in daily physical exercise during hospital admissions over a three-month period. Exercise sessions will be monitored and guided by M.D. Anderson physical therapists, a personal trainer, and Dr. Michael Rytting, pediatric oncologist. The personal trainer will meet with each participant for reinforcement and to provide an opportunity for exercise between hospitalizations. If results are positive, the study will be extended to a larger cohort of patients.
Read the detailed description
Patients who are staying at M.D. Anderson for inpatient chemotherapy treatment will take part in this study.
Participants in this study will be asked to take part in either mild physical exercise by themselves for 20 minutes a day, or group exercise sessions of moderate intensity once a day. Each participant will be evaluated by a physical therapist before participation.
Exercise programs will be designed for each individual. Participants will be encouraged to attend group sessions and continue the exercise program during the time they are outpatients. Participants will also have the opportunity to work with a personal trainer.
The group exercise program takes from 45 minutes to one hour, and will be performed under the guidance of certified physical therapists and a personal trainer in the Pedi-Dome located on the ninth floor of the Alkek Tower of M.D. Anderson. Participants who are not feeling well enough to come to the Pedi-Dome on a given day will have the opportunity to exercise in their hospital rooms with a physical therapist or trainer for 20 minutes.
The exercises are designed to promote flexibility, endurance, and strength. They include activities such as stretching, pilates-yoga, aerobics, step aerobic training, use of stationery bikes, and the use of therapeutic exercise balls, cuff weights, and dumbbells. The activities will be tailored to each individual's abilities and special needs.
The total length of participation in this study is three months. Participants will be asked to exercise each day that they are an inpatient and well enough to participate. Participants will be encouraged to continue exercise and participation in the exercise program when they are outpatients, but it will not be required. Participants will fill out short questionnaires and be evaluated for quality of life, fatigue, physical strength, and medical and nutritional status four times: at the time of enrollment in the study, and at one, two, and three months after enrollment. The questionnaires will take about 15 minutes to complete.
This is an investigational study. A total of 40 patients will take part in this study. All will be enrolled at M.D. Anderson.
- Being tested
- Exercise program, Questionnaires
- Keywords
- Leukemia, Lymphoma, Exercise, Quality of Life, Questionnaire, Survey
- Medical subject headings
- Leukemia, Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programBehavioural
Daily group or personal exercise programs designed to promote flexibility, endurance, and strength.
QuestionnairesBehavioural
Also called Survey
Questionnaires taking 15 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Exercise program | Experimental | Daily (Monday-Friday) 45-minute group physical exercise program during each hospital admission for three months or individual 20 minute session bedside. Receives: Behavioral: Exercise program; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Participation Rate
Participation in exercise program as measured through group attendance examined from study entry to three months later. Exercise participation rate was examined across 4 timepoints corresponding to inpatient chemotherapy treatments, and calculated as number of those exercising in each period divided by total participants in that period.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startFeb 2003
- Primary completionNov 2007
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha Askins, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502749
- Sponsor's protocol ID
- ID02-329
- Status last verified
- Oct 2011
- First submitted
- 16 Jul 2007
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety, and Effect of an Exercise Program for Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT00502749
- Acronym / sponsor ID
- ID02-329
- Keywords
- Leukemia, Lymphoma, Exercise, Quality of Life, Questionnaire, Survey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Nov 2007 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Jul 2007 (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.
This pilot study will examine the safety, feasibility, and effect on quality of life of moderate physical activity on adolescent and young adult patients who are admitted to the hospital periodically for routine chemotherapy. Patients will be asked to participate in daily physical exercise during hospital admissions over a three-month period. Exercise sessions will be monitored and guided by M.D. Anderson physical therapists, a personal trainer, and Dr. Michael Rytting, pediatric oncologist. The personal trainer will meet with each participant for reinforcement and to provide an opportunity for exercise between hospitalizations. If results are positive, the study will be extended to a larger cohort of patients.
Detailed description
Patients who are staying at M.D. Anderson for inpatient chemotherapy treatment will take part in this study.
Participants in this study will be asked to take part in either mild physical exercise by themselves for 20 minutes a day, or group exercise sessions of moderate intensity once a day. Each participant will be evaluated by a physical therapist before participation.
Exercise programs will be designed for each individual. Participants will be encouraged to attend group sessions and continue the exercise program during the time they are outpatients. Participants will also have the opportunity to work with a personal trainer.
The group exercise program takes from 45 minutes to one hour, and will be performed under the guidance of certified physical therapists and a personal trainer in the Pedi-Dome located on the ninth floor of the Alkek Tower of M.D. Anderson. Participants who are not feeling well enough to come to the Pedi-Dome on a given day will have the opportunity to exercise in their hospital rooms with a physical therapist or trainer for 20 minutes.
The exercises are designed to promote flexibility, endurance, and strength. They include activities such as stretching, pilates-yoga, aerobics, step aerobic training, use of stationery bikes, and the use of therapeutic exercise balls, cuff weights, and dumbbells. The activities will be tailored to each individual's abilities and special needs.
The total length of participation in this study is three months. Participants will be asked to exercise each day that they are an inpatient and well enough to participate. Participants will be encouraged to continue exercise and participation in the exercise program when they are outpatients, but it will not be required. Participants will fill out short questionnaires and be evaluated for quality of life, fatigue, physical strength, and medical and nutritional status four times: at the time of enrollment in the study, and at one, two, and three months after enrollment. The questionnaires will take about 15 minutes to complete.
This is an investigational study. A total of 40 patients will take part in this study. All will be enrolled at M.D. Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise program | Experimental | Behavioral: Exercise program, Behavioral: QuestionnairesDaily (Monday-Friday) 45-minute group physical exercise program during each hospital admission for three months or individual 20 minute session bedside. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents and young adults with leukemia/lymphoma between the ages of 12 and 25 years old.
- Leukemia/lymphoma patients admitted for chemotherapy with an anticipated hospital stay of at least three days.
Key exclusion criteria (1 listed)
- 1. Patients with an underlying condition that precludes moderate exercise due to safety.
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 |
|---|---|---|
| Exercise programDaily group or personal exercise programs designed to promote flexibility, endurance, and strength. | Behavioural | Exercise program |
| QuestionnairesAlso: SurveyQuestionnaires taking 15 minutes to complete. | Behavioural | Exercise program |
Primary outcome
Exercise Participation Rate
Time frame: Baseline to 3 months
Participation in exercise program as measured through group attendance examined from study entry to three months later. Exercise participation rate was examined across 4 timepoints corresponding to inpatient chemotherapy treatments, and calculated as number of those exercising in each period divided by total participants in that period.
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 17 Oct 2011.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Martha Askins, PhD principal investigator
M.D. Anderson Cancer Center
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 program and Questionnaires in people with Leukemia and Lymphoma, run by M.D. Anderson 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 2 inclusion and 1 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 17 Oct 2011. 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?
Exercise Participation Rate (time frame: Baseline to 3 months). 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 17 Oct 2011.