Clinical trial NCT03430271: Enhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: the ENGAGE Pilot Study
Official title: ENhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: The ENGAGE Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Somerville Council on Aging
First posted: 2018-02-12
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Accelerometry
timeFrame: 6 months
measure: Short physical performance battery (SPPB) test (an additional interim SPPB assessment will be conducted at week 12)
timeFrame: 6 months
measure: 400 meter walk
timeFrame: 6 months
measure: Quality of Well-Being
timeFrame: 6 months
measure: Depressive symptoms
timeFrame: 6 months
measure: Cognitive performance
timeFrame: 6 months
measure: Hand-Grip Strength
timeFrame: 6 months
measure: Nutrition Status
timeFrame: 6 months
measure: Falls history
timeFrame: 6 months
measure: Isometric Leg strength
timeFrame: 6 months
measure: Complex Walking Tasks (CWT's)
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
city: Somerville
country: United States
facility: Somerville Council on Aging Holland Street Senior Center
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Kieran Reid, PhD
role: PRINCIPAL_INVESTIGATOR
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