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

NCT03430271 | Completed

• 1 other identifier: 11624
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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.

Conditions

Mobility Limitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Accelerometry

  6 months

• Short physical performance battery (SPPB) test (an additional interim SPPB assessment will be conducted at week 12)

  6 months

• 400 meter walk

  6 months

• Quality of Well-Being

  6 months

• Depressive symptoms

  6 months

Study Arms (2)

Physical Activity (PA) Intervention

ACTIVE COMPARATOR

Other: Physical Activity Intervention

Health Education (HE) Intervention

PLACEBO COMPARATOR

Other: Healthy Aging Intervention

Interventions

Physical Activity Intervention OTHER

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.

Physical Activity (PA) Intervention

Healthy Aging Intervention OTHER

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.

Health Education (HE) Intervention

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• Somerville Council on Aging: collaborator

Study Sites (2)

Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Somerville Council on Aging Holland Street Senior Center

Somerville, Massachusetts, 02144, United States

Location

Related Publications (27)

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MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kieran Reid, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study assessor will be blinded to the treatment assignment. The study investigators and interventionists will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: February 12, 2018
• Study Start: May 12, 2015
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

US (2)