NCT00335491

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 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

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 30, 2011

Status Verified

September 1, 2011

Enrollment Period

4 years

First QC Date

June 8, 2006

Last Update Submit

September 28, 2011

Conditions

Bladder CancerBreast CancerColorectal CancerEsophageal CancerFatigueLung CancerLymphomaOvarian CancerProstate Cancer

Keywords

small cell lung cancernon-small cell lung cancercolon cancerprostate cancerbreast cancermale breast cancerfatiguelymphomaovarian epithelial cancerbladder canceresophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Patient perception and pattern of change

    To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status

    3 months of training followed by 6 and 12 months of no formal training

Secondary Outcomes (1)

  • Structural and function changes

    3 months of training followed by 6 and 12 months of no formal training

Interventions

exercise interventionBEHAVIORAL

12 weeks of 3x/week training on a recumbent eccentric stepper

Also known as: Eccentron
complementary or alternative medicine procedurePROCEDURE

12 weeks of 3x/week training on the eccentron

Also known as: Eccentron
fatigue assessment and managementPROCEDURE

The visual analog scale will be used to assess muscle soreness from the previous exercise session

physical therapyPROCEDURE

12 weeks of 3x/week training on the eccentron

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • 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.

    PMID: 21272338DERIVED

MeSH Terms

Conditions

Urinary Bladder NeoplasmsBreast NeoplasmsColorectal NeoplasmsEsophageal NeoplasmsFatigueLung NeoplasmsLymphomaOvarian NeoplasmsProstatic NeoplasmsSmall Cell Lung CarcinomaCarcinoma, Non-Small-Cell LungColonic NeoplasmsBreast Neoplasms, MaleCarcinoma, Ovarian Epithelial

Interventions

TherapeuticsPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Rehabilitation

Study Officials

  • Paul C. LaStayo, PhD, PT

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 12, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 30, 2011

Record last verified: 2011-09

Locations

US(1)