Rapid Easy Strength Training (REST) to Improve Function in Late Stage Cancer
REST
Phase II Randomized Controlled Trial of Rapid and Easy Strength Training to Preserve Function in Late Stage Cancer
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 cancer
Started Jun 2010
Shorter than P25 for phase_2 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 12, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedNovember 18, 2023
April 1, 2015
5 months
April 12, 2011
November 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ambulatory Post Acute Care Basic Mobility Short Form
Patient reported outcome with 18 items assessed functionality in basic mobility. Response option for all items is a 4 level Likert scale
8 weeks
Secondary Outcomes (3)
Ambulatory Post Acute Care Short Form Daily Activities
8 weeks
Linear Analoge Self Assessment of Quality of Life
8 weeks
FACIT-F
8 weeks
Study Arms (2)
REST
EXPERIMENTALParticipants instructed in individualized Rapid Easy Strength Training and pedometer-based walking programs
Wait list control
NO INTERVENTIONParticipants instructed in REST after completing week 8 outcome measures
Interventions
Instruction in an individualized rapid easy strength training (isotonic with therabands) and pedometer-based walking programs.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2011
First Posted
April 13, 2011
Study Start
June 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
November 18, 2023
Record last verified: 2015-04