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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01334983
First received: April 12, 2011
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Cancer
Behavioral: REST
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase II Randomized Controlled Trial of Rapid and Easy Strength Training to Preserve Function in Late Stage Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Ambulatory Post Acute Care Basic Mobility Short Form [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Ambulatory Post Acute Care Short Form Daily Activities [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patient reported outcome with 15 items assessing functionality with respect to the performance of activities of daily living.

  • Linear Analoge Self Assessment of Quality of Life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    7 item patient reported outcome assessing over-all quality of life and quality of life domains, e.g. mental, social, etc.

  • FACIT-F [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patient reported outcome assessing overall quality of life among patients with cancer and fatigue


Enrollment: 68
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334983

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Andrea L. Cheville, Mayo Clinic, Rochester MN
ClinicalTrials.gov Identifier: NCT01334983     History of Changes
Other Study ID Numbers: 09-007108
Study First Received: April 12, 2011
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
cancer
function
fatigue
late stage
metastases
quality of life
functional decline in cancer

ClinicalTrials.gov processed this record on July 20, 2014