Enhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: the ENGAGE Pilot Study (ENGAGE)

February 12, 2018 updated by: Tufts University

ENhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: The ENGAGE Pilot Study

This study will be conducted to determine the safety and feasibility of translating a physical activity intervention (LIFE Study) into a community setting. Study outcomes include physical performance, safety, and feasibility of conducting the LIFE PA intervention in a community setting.

Study Overview

Detailed Description

Older adults who lose their mobility experience a poorer quality of life, are less likely to remain independent in the community and have higher rates of chronic disease, falls and mortality. Recent results from the Lifestyle Interventions and Independence for Elders (LIFE) study demonstrated that a structured program of physical activity (PA) reduced the onset of major mobility disability in at-risk older adults by up to 28% over a 2.6 year period. Despite the public health significance of this study, to-date no study has attempted to translate LIFE PA to broader populations of at-risk older adults in community-based settings. To address this knowledge gap, and to aid the design of a larger pragmatic trial of LIFE PA in community-based settings, the investigators conducted the ENhancing independence using Group-based community interventions for healthy AGing in Elders (ENGAGE) pilot study. The investigators examined the safety and feasibility of translating LIFE PA into the existing infrastructure of a community-based senior center. The investigators also explored the preliminary real-world effectiveness of PA on physical performance and several other important health related outcomes for older persons, including cognitive function, quality of life, depressive symptoms and frequency of falling.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • 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

    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Jean Mayer Human Nutrition Research Center on Aging at Tufts University
      • Somerville, Massachusetts, United States, 02144
        • Somerville Council on Aging Holland Street Senior Center

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

Ages Eligible for Study

65 years to 89 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and Females age ≥ 65 and ≤89 years
  • Community dwelling
  • Short Physical Performance Battery ≤ 9
  • No participation in a structured physical activity program within the previous 3 months
  • Willingness to be randomized and participate for 24 weeks
  • Written permission from primary care physician
  • Having obtained his/her informed consent

Exclusion Criteria:

  • Acute or terminal illness
  • Modified Mini-Mental State Examination Score <80(<76 if African American)*
  • Myocardial Infarction in the previous 6 months
  • Symptomatic coronary artery disease
  • Upper or lower extremity fracture in the previous 6 months
  • Resting blood pressure >180/100 mmHg
  • Unable to communicate due to severe hearing loss or speech disorder
  • Severe visual impairment that may preclude participation in the study assessments or interventions
  • Non-English speaking

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physical Activity (PA) Intervention
Participants in this arm will complete exercise sessions 1 time per week for 24 weeks. An optional, second PA session will also be offered to PA participants. The exercise sessions will be multimodal and involve walking, lower extremity strengthening exercises, flexibility and balance training.
Placebo Comparator: Health Education (HE) Intervention
Participants will attend health education workshops on topics of relevance to older adults. Workshops will be offered weekly in a group setting, and participants will be required to attend biweekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
This study will assess the safety of translating LIFE PA to a real-world community based setting by monitoring the occurrence of adverse events and serious adverse events.
Time Frame: 6 months
Safety will be measured by the number of adverse events and serious adverse events. The investigators will compare the rates of adverse events and serious adverse events between the physical activity and healthy aging education intervention randomized arms.
6 months
This study will assess the feasibility of translating LIFE PA to a real-world community based setting with adequate PA adherence in the community by measuring intervention adherence and retention.
Time Frame: 6 months
Intervention adherence is measured by percent attendance (number of visits attended/total number of scheduled visits). Successful adherence will be defined by an attendance rate of >60%. This will be used as an index of feasibility.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accelerometry
Time Frame: 6 months
Accelerometry will objectively measure levels of physical activity intensity (light/moderate) and sedentary time. Accelerometry will be measured by GT3X+, Actigraph, Pensacola, FL. The actigraph will be worn for a 7-day period during waking hours during baseline and follow-up. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks
6 months
Short physical performance battery (SPPB) test (an additional interim SPPB assessment will be conducted at week 12)
Time Frame: 6 months
The SPPB test will be evaluated using a 4m gait speed test, chair stand test (consisting of five consecutive chair stands), and a balance test (measured by a side-by-side, semi-tandem, and full tandem stand). This test will assess the time to complete a 4m walk and a chair stand test, as well as the time each participant can hold the balance positions (up to 10 seconds). Time will be measured in minutes and seconds. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.
6 months
400 meter walk
Time Frame: 6 months
The 400 meter walk will be a timed measurement of 10 laps around a 20 meter course or until the participant is unable to continue. Time will be measured in minutes and seconds. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.
6 months
Quality of Well-Being
Time Frame: 6 months
This assessment will be measured using the Quality of Well-Being (QWB) Scale questionnaire. This scale provides a comprehensive measure of health-related quality of life that assesses health symptoms and functioning. The questionnaire is scored using a 0 to 1.0 scale (0 representing death, 1.0 representing asymptomatic full function). This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.
6 months
Depressive symptoms
Time Frame: 6 months
Depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D), which is designed to measure depressive symptomology in the general population. The Scale consists of 20 questions, which are assigned a response score of 0, 1, 2 or 3 depending upon whether the item is worded positively or negatively. Possible range of total scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. A cutoff score of 16 or greater reflects individuals at risk for clinical depression. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.
6 months
Cognitive performance
Time Frame: 6 months
Cognitive performance will be assessed using the Digit Symbol Substitution Test (DSST). The DSST is a measure of attention and perceptual speed in which subjects are given a series of numbered symbols and then asked to draw the appropriate symbols below a list of random numbers. The score is the number of correctly made matches in 2 minutes. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.
6 months
Hand-Grip Strength
Time Frame: 6 months
Grip strength will be measured in the dominant hand with a Jamar Handheld Dynamometer. Participants will be asked to perform a maximal isometric contraction. Strength will be measured in kilograms. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.
6 months
Nutrition Status
Time Frame: 6 months
Nutrition Status will be assessed using the Mini Nutrition Assessment, Short Form (MNA-SF). The MNA-SF is a validated nutrition screening assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.
6 months
Falls history
Time Frame: 6 months
Participants will be asked about any recent falls they have experienced at each assessment visit and will be asked to record any falls that they experience throughout the trial on a calendar provided by the study interventionist. Falls history will be reported from baseline to 24 weeks.
6 months
Isometric Leg strength
Time Frame: 6 months
Maximal isometric leg strength will be assessed using a portable electronic weight scale. Participants will be instructed to kick their leg as hard as possible three times on each leg. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.
6 months
Complex Walking Tasks (CWT's)
Time Frame: 6 months
Subjects will be asked to walk on an even surface for 7 meters as fast as possible while remaining safe. They will then be asked to repeat the walk at their usual pace while simultaneously subtracting 3 from 50 and keep subtracting until the 7 meter walk is completed. The walk will be timed (measured in minutes with a stop watch and each subtraction will be recorded. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.
6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Kieran Reid, PhD, Tufts University

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 (Actual)

May 12, 2015

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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