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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
aerobic or resistance training

Locations

Country Name City State
United States Brooke Army Medical Center Fort Sam Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
TriService Nursing Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary quality of life 12-weeks No
Secondary exercise tolerance 12-weeks No
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