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Completed

NCT Number: NCT00335491

Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older 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.

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Key information

Conditions

Bladder Cancer Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

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

Other names: Eccentron

complementary or alternative medicine procedure

Procedure

12 weeks of 3x/week training on the eccentron

Other names: Eccentron

fatigue assessment and management

Procedure

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

physical therapy

Procedure

12 weeks of 3x/week training on the eccentron

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A RENEW Intervention for Elderly Cancer Survivors

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 12, 2006
Registry last updated
Sep 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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