Skip to content

Home Based Exercise Program for Elderly Cancer Patients

Single Institution Randomized Controlled Study of a Home Based Exercise Program to Reduce Functional Decline, Cancer Related Fatigue (CRF and Improve Quality of Life for the Elderly Gynecologic Oncology Patient)

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01990066
Enrollment
8
Registered
2013-11-21
Start date
2014-03-31
Completion date
2014-11-30
Last updated
2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Related Fatigue

Keywords

Quality of Life, Physical Function

Brief summary

Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient Problem: Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy? Support: Fatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010). The National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue. Methods: This is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care. Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance. The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion). Conclusion: PT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.

Interventions

Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching. They will receive a home exercise DVD and flip ring of exercises. Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer. Subjects will record their exercise on a log and return on day 1 of every cycle.

Sponsors

Oncology Nursing Centers for Excellence
CollaboratorUNKNOWN
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Endometrial, Ovarian, Cervix, Vaginal Cancer Initiating Chemotherapy * Age greater than or equal to 65yrs * ECOG (Eastern Cooperative Oncology Group) performance status less than 3 * No current physical therapy intervention * English speaking

Exclusion criteria

* Non-gynecologic malignancy * Recurrent cancer * Receiving radiation alone * Gait or balance disturbance

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Cancer Related Fatigue (CRF)Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point)CRF will be evaluated using the FACIT-F tool.

Secondary

MeasureTime frameDescription
Quality of Life Improvement (QOL)Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)QOL will be evaluated using the NHANES and FACIT-F tools.
Reduction in Physical Functional DeclineBaseline and +/- 7days of 3 weeks post 6th cycle (end point)Physical function will be evaluated using the Berg Balance Test and 6 Min Walk Test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026