Activity Monitoring and Counseling in a Geriatric Population

June 5, 2014 updated by: Warren G. Thompson, Mayo Clinic

Activity Monitoring and Counseling in a Geriatric Population: a Randomized Trial

The goal of the study is to determine if a Fitbit, a kind of accelerometer, provides feedback to subjects combined with an activity counseling program will result in an increase in physical activity of at least 20%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria

  • Volunteers from the public including subjects in the independent living section of Assisted Living Facilities between the ages of 65 and 85.
  • Those over 85 may participate with their personal physician's consent.
  • BMI 25-40 kg/m2 OR a waist circumference 88 cm or greater in women or 102 cm or greater in men
  • Sedentary (no more than 30 minutes of vigorous or 90 minutes of moderate activity per week)
  • Complete a Timed Get Up and Go test in <= 20 seconds
  • If walking is done with an assistive device, the subject must have no history of falling with the use of said device)

  • Subjects will complete the Physical Activity Readiness Questionnaire - Revised (PARQ-R) which is as follows:

    1. Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?
    2. Do you feel pain in your chest when you do physical activity?
    3. In the past month, have you had chest pain when you were not doing physical activity?
    4. Do you lose your balance because of dizziness, or do you ever lose consciousness?
    5. Do you have a bone or joint problem that could be made worse by a change in your physical activity?
    6. Is your doctor currently prescribing drugs (for example, water pills) for your blood pressure or heart condition?
    7. Do you know of any other reason why you should not do physical activity? Subjects who respond "yes" to any of the above questions will require written permission from their physician to participate in this study.

Exclusion criteria:

  • Significant cognitive impairment (score on Mini-Cog less than 3).
  • Diabetics on medication
  • Subjects who should not participate in an exercise program will not be eligible for the study.
  • Angina or a history of myocardial infarction
  • Cancer (other than non-melanoma skin cancer) will not be eligible.
  • Uncompensated liver disease
  • Uncompensated thyroid disease
  • Severe osteoporosis
  • Any medical condition which might lead to weight loss or weight gain
  • Patients on the following medications: antidepressants (those on bupropion and stable doses of selective serotonin re-uptake inhibitors (SSRIs) and trazodone will be included), antipsychotics, topiramate, orlistat, or phentermine (Patients on statins will be eligible if no change in their medication is planned over the next 6 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Accelerometer feedback and lifestyle counseling
The accelerometer, Fitbit, will be worn continuously. Fitbit can provide feedback to subjects about their physical activity. Subjects will wear the Fitbit for two weeks (without feedback) to obtain baseline activity data. The experimental group will then be instructed on use of the fitbit. Subjects will meet with the exercise counselor who will use accelerometer data to provide feedback and counseling to help the user increase their activity by at least 20% each day. In subjects who achieve an increase of 20%, the counseling will focus either on maintaining activity levels or increasing activity further depending on the desire of the subject. Counseling will be provided once weekly by phone and in person at least once a month. Following the 26th week the experimental subjects will continue to wear the Fitbit and receive feedback about their activity levels for an additional 24 weeks, but they will no longer receive counseling.
Other: Accelerometer feedback and lifestyle counseling
Subjects will meet with the exercise counselor who will use accelerometer data to provide feedback and counseling to help the user increase their activity by at least 20% each day. In subjects who achieve an increase of 20%, the counseling will focus either on maintaining activity levels or increasing activity further depending on the desire of the subject. Counseling will be provided once weekly by phone and in person at least once a month. Following the 26th week the experimental subjects will continue to wear the Fitbit and receive feedback about their activity levels for an additional 24 weeks, but they will no longer receive counseling. The control group will receive no counseling for the first 26 weeks of the study and will then crossover to get accelerometry feedback and counseling for the last 24 weeks of the study.
Experimental: Accelerometer without Feedback
The accelerometer, Fitbit, will be worn continuously. Subjects will wear the Fitbit for two weeks (without feedback) to obtain baseline activity data. The control group will continue to wear the fitbit for the next 24 weeks without any feedback or activity counseling. Following the 26th week of the study, the subjects in the control group will complete the same program given to the experimental group in weeks 2 through 26.
Other: Accelerometer without Feedback
The accelerometer, Fitbit, will be worn continuously. Fitbit can provide feedback to subjects about their physical activity. Subjects will wear the Fitbit for two weeks (without feedback) to obtain baseline activity data. The experimental group will then be instructed on use of the fitbit. This group will receive feedback from the accelerometer for the remainder of the study. The control group will wear the Fitbit but receive no feedback for the first 26 weeks of the study. For the last 24 weeks they will crossover and receive feedback from the Fitbit accelerometer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Activity units as determined by Accelerometry
Time Frame: 6 and 12 months
6 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Fasting lipid profile
Time Frame: 6 and 12 months
6 and 12 months
Body weight in kilograms
Time Frame: 6 and 12 months
6 and 12 months
Body fat by bone density scan (DEXA)
Time Frame: 6 and 12 months
6 and 12 months
Waist to hip ratio
Time Frame: 6 and 12 months
6 and 12 months
Fasting glucose
Time Frame: 6 and 12 months
6 and 12 months
Hemoglobin A1c
Time Frame: 6 and 12 months
6 and 12 months
Fasting insulin
Time Frame: 6 and 12 months
6 and 12 months
high sensitivity c-reactive protein
Time Frame: 6 and 12 months
6 and 12 months
Body Mass Index
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
JR Albert Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Warren Thompson, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-008672

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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