Clinical trial NCT00335491: Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors
Official title: A RENEW Intervention for Elderly Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Breast Cancer
Colorectal Cancer
Esophageal Cancer
Fatigue
Lung Cancer
Lymphoma
Ovarian Cancer
Prostate Cancer
Keywords: small cell lung cancer
non-small cell lung cancer
colon cancer
prostate cancer
breast cancer
male breast cancer
fatigue
lymphoma
ovarian epithelial cancer
bladder cancer
esophageal cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-06-12
Enrollment: 49
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Patient perception and pattern of change
timeFrame: 3 months of training followed by 6 and 12 months of no formal training
Secondary outcomes:
measure: Structural and function changes
timeFrame: 3 months of training followed by 6 and 12 months of no formal training
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Paul C. LaStayo, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: LaStayo PC, Marcus RL, Dibble LE, Smith SB, Beck SL. Eccentric exercise versus usual-care with older cancer survivors: the impact on muscle and mobility--an exploratory pilot study. BMC Geriatr. 2011 Jan 27;11:5. doi: 10.1186/1471-2318-11-5.