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

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT00335491

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Breast Cancer Colorectal Cancer Esophageal Cancer Fatigue Lung Cancer Lymphoma Ovarian Cancer Prostate Cancer	Behavioral: exercise intervention Procedure: complementary or alternative medicine procedure Procedure: fatigue assessment and management Procedure: physical therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

A RENEW Intervention for Elderly Cancer Survivors

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Outcome Measures

Primary Outcome Measures

Patient perception and pattern of change [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

Secondary Outcome Measures

Structural and function changes [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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