NeoplasmsNCT00237926
Comparing Aerobic to Resistance Training in Recovery From Cancer
A study testing Exercise in people with Neoplasms, run by TriService Nursing Research Program at 1 site in United States.
Trial summary
The purpose of this study is to compare the health outcomes of a 12-week exercise program focused on aerobic training (using a treadmill) to a 12-week exercise program focused on resistance training (using Thera-Bands) in sedentary patients within 6 months of completing treatment for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Mar 2008
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a biopsy-proven cancer diagnosis
- be within six months of having completed chemotherapy or radiation therapy for treatment for cancer as determined by the primary physician
- be ambulatory but sedentary (i. e., has not followed an exercise regimen of a minimum of 3 times per week for at least 20 minutes each session over the previous six weeks)
- have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 asymptomatic) or 1 (symptomatic, fully ambulatory)
- be at least 18 years old
- be able to read and speak English
- have a medical statement from either the patient's primary care provider or the primary oncologist indicating that participation in the program is not medically contraindicated
Who cannot join
- following an exercise regimen a minimum of 3 times per week for at least 20 minutes each session within the previous 6 weeks
- bone or joint destruction that could be aggravated with exercise
- severe cognitive impairment identified by either the patient's medical care provider or by the study team
- neuropathy-sensory common toxicity criteria (CTC) grade 3 (sensory loss or paresthesia interfering with activities of daily living) or grade 4 (permanent sensory loss that interferes with function) peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
The purpose of this study is to compare the health outcomes of a 12-week exercise program focused on aerobic training (using a treadmill) to a 12-week exercise program focused on resistance training (using Thera-Bands) in sedentary patients within 6 months of completing treatment for cancer.
- Conditions
- Neoplasms
- Being tested
- Exercise
- Keywords
- Sleep, Fatigue, Exercise tolerance, Quality of life, Health status
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
aerobic or resistance training
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | aerobic exercise Receives: Behavioral: Exercise |
| 2 | Experimental | Resistance Training Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Measured: 12-weeks
Secondary outcomes (1)
exercise tolerance
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriService Nursing Research Program
- Sponsor type
- University, hospital or other
- Investigators
- Stacey Young-McCaughan, RN, PhD, Principal investigator, United States Department of Defense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237926
- Sponsor's protocol ID
- N05-006
- Status last verified
- Jul 2008
- First submitted
- 11 Oct 2005
- Last updated
- 1 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Aerobic to Resistance Training in Recovery From Cancer
- ClinicalTrials.gov ID
- NCT00237926
- Acronym / sponsor ID
- N05-006
- Conditions
- Neoplasms
- Keywords
- Sleep, Fatigue, Exercise tolerance, Quality of life, Health status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- TriService Nursing Research ProgramUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Mar 2008 (actual)
- First posted
- 13 Oct 2005 (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 the health outcomes of a 12-week exercise program focused on aerobic training (using a treadmill) to a 12-week exercise program focused on resistance training (using Thera-Bands) in sedentary patients within 6 months of completing treatment for cancer.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Exerciseaerobic exercise |
| 2 | Experimental | Behavioral: ExerciseResistance Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- have a biopsy-proven cancer diagnosis
- be within six months of having completed chemotherapy or radiation therapy for treatment for cancer as determined by the primary physician
- be ambulatory but sedentary (i. e., has not followed an exercise regimen of a minimum of 3 times per week for at least 20 minutes each session over the previous six weeks)
- have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 asymptomatic) or 1 (symptomatic, fully ambulatory)
- be at least 18 years old
Key exclusion criteria (4 listed)
- following an exercise regimen a minimum of 3 times per week for at least 20 minutes each session within the previous 6 weeks
- bone or joint destruction that could be aggravated with exercise
- severe cognitive impairment identified by either the patient's medical care provider or by the study team
- neuropathy-sensory common toxicity criteria (CTC) grade 3 (sensory loss or paresthesia interfering with activities of daily living) or grade 4 (permanent sensory loss that interferes with function) peripheral neuropathy
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 |
|---|---|---|
| Exerciseaerobic or resistance training | Behavioural | 1, 2 |
Primary outcome
quality of life
Time frame: 12-weeks
1 secondary outcome
exercise tolerance
Time frame: 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 1 Aug 2008.
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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.
Stacey Young-McCaughan, RN, PhD principal investigator
United States Department of Defense
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 Neoplasms, run by TriService Nursing Research Program 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 7 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 1 Aug 2008. 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?
quality of life (time frame: 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 1 Aug 2008.