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Clinical Trials/NCT01833507
NCT01833507
Completed
Phase 2

Relationship Between Physical Activity and Health Outcomes in Overweight and Obese Medically Complex Adults, a Randomized Trial

Mayo Clinic1 site in 1 country130 target enrollmentApril 2013
ConditionsOverweightObese

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Overweight
Sponsor
Mayo Clinic
Enrollment
130
Locations
1
Primary Endpoint
Gait, Grip and Walking
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Obesity is common in adults with complex medical problems with ensuing complications afterwards. Obese patients suffer higher mortality and impaired functional status often as a result of their obesity. One primary goal to reduce both obesity and improve functional status is exercise. The investigators hypothesize that a simple exercise intervention with limited behavioral goal-setting will reduce weight and increase functional status compared to usual care. As a secondary measure, the investigators hypothesize that using this intervention will reduce hospital admissions and ER visits.

Detailed Description

We are enrolling up to 150 subjects where half will receive a pedometer and behavioral goal-setting at enrollment and half will receive a pedometer and goal-setting 2 months later. It is a 4 month study. Our aims are as follows: Primary Aim: Determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients. Second Primary aim: To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients. Secondary Aim: Determine the relationship between the number of hospitalizations in patients randomized to a self-exercise program compared to usual care in complex medical patients.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul Takahashi,

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Patients will be over the age of 18
  • Have a BMI over 25.0 kg/m
  • Have a Minnesota Medical Tiering concerning medical complexity of 3-4.

Exclusion Criteria

  • Patients will be excluded if they have clinically documented dementia.
  • Subjects will be community dwelling and patients living in skilled nursing facilities will be excluded.
  • Subjects residing within a correctional institution will be excluded.
  • Subject is a female patient who is currently pregnant.

Outcomes

Primary Outcomes

Gait, Grip and Walking

Time Frame: 4 months

Determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients.

weight loss

Time Frame: 4 months

To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.

Secondary Outcomes

  • number of hospitalizations(4 months)

Study Sites (1)

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