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

September 28, 2011 updated by: Paul LaStayo, University of Utah

A RENEW Intervention for Elderly Cancer Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute At University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient perception and pattern of change Time Frame: 3 months of training followed by 6 and 12 months of no formal training	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural and function changes Time Frame: 3 months of training followed by 6 and 12 months of no formal training	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	3 months of training followed by 6 and 12 months of no formal training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Paul C. LaStayo, PhD, PT, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria