Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Breast Cancer

Bladder Cancer

Esophageal Cancer

Lung Cancer

Lymphoma

Ovarian Cancer

Fatigue

Prostate Cancer

Colorectal Cancer

Treatments

Procedure: complementary or alternative medicine procedure

Procedure: fatigue assessment and management

Behavioral: exercise intervention

Procedure: physical therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00335491

UUMC-R21CA114523

R21CA114523 (U.S. NIH Grant/Contract)

P30CA042014 (U.S. NIH Grant/Contract)

14551

Details and patient eligibility

About

RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer survivors. It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.

PURPOSE: This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.

Full description

OBJECTIVES:

Compare the perception of, and the patterns of change in fatigue, weakness, physical activity level, and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work (RENEW) vs standard care.
Compare changes in muscle structure, function (strength + power production and metabolic function) and mobility.
Evaluate the patient's adherence to and satisfaction with the RENEW intervention.

OUTLINE: This is a prospective, randomized, controlled, longitudinal study. Patients are randomized to 1 of 2 intervention arms.

Arm I: Patients undergo resistance exercise via negative-eccentric work (RENEW), using a special seated stationary leg exercise machine, 3 times a week for up to 12 weeks. Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW.
Arm II: Patients receive standard care. In both arms, fatigue, weakness, physical activity, functional status, muscle structure and function, and mobility are assessed at baseline and then at 12 weeks after completion of study intervention. Fatigue and weakness are also assessed weekly during study intervention. Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Enrollment

49 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Survivor of breast, prostate, colon, lung, lymphoma, ovarian, bladder, or esophageal cancer with no evidence of disease
At least moderate levels of fatigue and/or weakness
Impaired mobility but ambulatory and medically able to participate in an exercise regimen
- No impaired knee flexion, defined as < 90º

PATIENT CHARACTERISTICS:

Folstein Mini-Mental Status Examination score ≥ 23
No extreme claustrophobia
No diagnosed chronic fatigue syndrome/disorder
No neurological impairments, including the following:
- Central nervous system disorder (e.g., multiple sclerosis or Parkinson's disease)
- Neurological insult (cerebrovascular attack) that manifests in a mobility disorder
No myopathic disease (e.g., focal myopathy) that effects skeletal muscle structure/function
No rheumatological disease that has an effect on muscle and/or mobility (e.g., polymyalgia rheumatica)

PRIOR CONCURRENT THERAPY:

More than 6 months since prior regular aerobic or resistance exercise
- Regular exercise defined as 2-3 times per week
At least 6 months since prior cancer treatment (surgery, radiation, and/or chemotherapy )
No concurrent cancer-related treatment other than hormonal therapy