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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Mobility Limitation

Intervention / Treatment
-----------------
* Other: Physical Activity Intervention
* Other: Healthy Aging Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The ENGAGE Somerville Study is designed as a single blind, randomized-controlled, parallel-group pilot study. This study plans to enroll up to 50 participants to be randomized into the PA or health aging intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical Activity (PA) Intervention<br> | Other: Physical Activity Intervention<br>* 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.<br>|
| Placebo Comparator: Health Education (HE) Intervention<br> | Other: Healthy Aging Intervention<br>* 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.<br>|

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. | 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. | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 |