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Rapid Easy Strength Training (REST) to Improve Function in Late Stage Cancer (REST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01334983
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
Andrea Cheville, Mayo Clinic

Brief Summary:
The purpose of this study is to determine whether a gentle physical conditioning program comprised of isotonic resistive strengthening and pedometer-directed walking can improve the physical functioning and fatigue of patients with late stage lung or colon cancer.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: REST Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase II Randomized Controlled Trial of Rapid and Easy Strength Training to Preserve Function in Late Stage Cancer
Study Start Date : June 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: REST
Participants instructed in individualized Rapid Easy Strength Training and pedometer-based walking programs
Behavioral: REST
Instruction in an individualized rapid easy strength training (isotonic with therabands) and pedometer-based walking programs.

No Intervention: Wait list control
Participants instructed in REST after completing week 8 outcome measures

Primary Outcome Measures :
  1. Ambulatory Post Acute Care Basic Mobility Short Form [ Time Frame: 8 weeks ]
    Patient reported outcome with 18 items assessed functionality in basic mobility. Response option for all items is a 4 level Likert scale

Secondary Outcome Measures :
  1. Ambulatory Post Acute Care Short Form Daily Activities [ Time Frame: 8 weeks ]
    Patient reported outcome with 15 items assessing functionality with respect to the performance of activities of daily living.

  2. Linear Analoge Self Assessment of Quality of Life [ Time Frame: 8 weeks ]
    7 item patient reported outcome assessing over-all quality of life and quality of life domains, e.g. mental, social, etc.

  3. FACIT-F [ Time Frame: 8 weeks ]
    Patient reported outcome assessing overall quality of life among patients with cancer and fatigue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of Stage III or IV NSCLC or extensive stage SCLC, or Stage IV colon cancer
  • fluency in the English language
  • Intact cognitive status (Folstein mini-mental score > 25).

Exclusion Criteria:

  • Pain numeric rating scale (NRS) scores > 7/10,
  • Fatigue NRS score > 8/10,
  • paralysis of > 2 limbs (< antigravity strength in all major muscle groups),
  • Severe cerebellar ataxia,
  • Chronic (> 1 year) non-cancer pain either >5/10 or causing the patient to apply for or receive disability payments.
  • Severe medical or psychiatric co-morbidities such as major depression or unstable angina

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01334983

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Responsible Party: Andrea Cheville, PI, Mayo Clinic Identifier: NCT01334983    
Other Study ID Numbers: 09-007108
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Andrea Cheville, Mayo Clinic:
late stage
quality of life
functional decline in cancer