Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors
NCT ID: NCT00335491
Last Updated: 2011-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2006-03-31
2010-03-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Interventions
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exercise intervention
12 weeks of 3x/week training on a recumbent eccentric stepper
complementary or alternative medicine procedure
12 weeks of 3x/week training on the eccentron
fatigue assessment and management
The visual analog scale will be used to assess muscle soreness from the previous exercise session
physical therapy
12 weeks of 3x/week training on the eccentron
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Utah
OTHER
Responsible Party
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Paul LaStayo
PT, PhD
Principal Investigators
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Paul C. LaStayo, PhD, PT
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Countries
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References
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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.
Other Identifiers
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UUMC-R21CA114523
Identifier Type: -
Identifier Source: secondary_id
14551
Identifier Type: -
Identifier Source: org_study_id
NCT00286715
Identifier Type: -
Identifier Source: nct_alias