Rapid Easy Strength Training (REST) to Improve Function in Late Stage Cancer - Full Text View

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:

MedlinePlus related topics: Cancer Fatigue

U.S. FDA Resources

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

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 May 23, 2013