Neoplasms Clinical Trial
Official title:
Comparing Aerobic to Resistance Training in Recovery From Cancer
| NCT number | NCT00237926 |
| Other study ID # | N05-006 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | October 11, 2005 |
| Last updated | July 29, 2008 |
| Start date | November 2005 |
| Verified date | July 2008 |
| Source | Brooke Army Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | |
| Est. primary completion date | March 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| TriService Nursing Research Program |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | quality of life | 12-weeks | No | |
| Secondary | exercise tolerance | 12-weeks | No |
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