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

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ClinicalTrials.gov Identifier: NCT03430271
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Somerville Council on Aging
Information provided by (Responsible Party):
Tufts University

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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Other: Physical Activity Intervention Other: Healthy Aging Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: The study assessor will be blinded to the treatment assignment. The study investigators and interventionists will not be blinded.
Primary Purpose: Treatment
Official Title: ENhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: The ENGAGE Pilot Study
Actual Study Start Date : May 12, 2015
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Arm Intervention/treatment
Active Comparator: Physical Activity (PA) Intervention Other: Physical Activity 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 Other: Healthy Aging 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430271


Locations
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United States, Massachusetts
Jean Mayer Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Somerville Council on Aging Holland Street Senior Center
Somerville, Massachusetts, United States, 02144
Sponsors and Collaborators
Tufts University
Somerville Council on Aging
Investigators
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Principal Investigator: Kieran Reid, PhD Tufts University

Publications:

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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT03430271     History of Changes
Other Study ID Numbers: 11624
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Mobility Limitation
Signs and Symptoms