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

Primary Purpose

Bladder Cancer, Breast Cancer, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise intervention
complementary or alternative medicine procedure
fatigue assessment and management
physical therapy
Sponsored by
University of Utah
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer focused on measuring 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

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huntsman Cancer Institute at University of Utah

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Structural and function changes
To explore whether changes in muscle structure and function (strength and power production and metabolic function) and mobility occur following twelve weeks of training with RENEW

Full Information

First Posted
June 8, 2006
Last Updated
September 28, 2011
Sponsor
University of Utah
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00335491
Brief Title
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

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
exercise intervention
Other Intervention Name(s)
Eccentron
Intervention Description
12 weeks of 3x/week training on a recumbent eccentric stepper
Intervention Type
Procedure
Intervention Name(s)
complementary or alternative medicine procedure
Other Intervention Name(s)
Eccentron
Intervention Description
12 weeks of 3x/week training on the eccentron
Intervention Type
Procedure
Intervention Name(s)
fatigue assessment and management
Intervention Description
The visual analog scale will be used to assess muscle soreness from the previous exercise session
Intervention Type
Procedure
Intervention Name(s)
physical therapy
Intervention Description
12 weeks of 3x/week training on the eccentron
Primary Outcome Measure Information:
Title
Patient perception and pattern of change
Description
To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status
Time Frame
3 months of training followed by 6 and 12 months of no formal training
Secondary Outcome Measure Information:
Title
Structural and function changes
Description
To explore whether changes in muscle structure and function (strength and power production and metabolic function) and mobility occur following twelve weeks of training with RENEW
Time Frame
3 months of training followed by 6 and 12 months of no formal training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul C. LaStayo, PhD, PT
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21272338
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.
Results Reference
derived

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

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