NCT00237926

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

Enrollment Period

2.3 years

First QC Date

October 11, 2005

Last Update Submit

July 29, 2008

Conditions

Neoplasms

Keywords

SleepFatigueExercise toleranceQuality of lifeHealth status

Outcome Measures

Primary Outcomes (1)

  • quality of life

    12-weeks

Secondary Outcomes (1)

  • exercise tolerance

    12-weeks

Study Arms (2)

1

EXPERIMENTAL

aerobic exercise

Behavioral: Exercise

2

EXPERIMENTAL

Resistance Training

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

aerobic or resistance training

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

NeoplasmsFatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stacey Young-McCaughan, RN, PhD

    United States Department of Defense

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 13, 2005

Study Start

November 1, 2005

Primary Completion

March 1, 2008

Last Updated

August 1, 2008

Record last verified: 2008-07

Locations

US(1)