NCT03624049

Brief Summary

The goal of this study is to reduce risk of falls and social isolation in older adults age 50+ through participation in community based health and exercise programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
671

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

3.1 years

First QC Date

July 12, 2018

Last Update Submit

August 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Social Isolation

    The Duke Social Support Index (DSSI) is an 11 item questionnaire with a total score between 11 and 33 with higher scores indicating increased social connection and lower scores indicating higher social isolation.

    Change in Duke Social Support Index from baseline will be measured at 8 weeks and 6 months.

Secondary Outcomes (3)

  • Number of falls in the past 3 months - Reduce Falls

    Items will be measured at Baseline, 8 weeks, and 6 months

  • Number of falls with injury in the past 3 months - Reduce Falls

    Items will be measured at Baseline, 8 weeks, and 6 months

  • Change in Loneliness

    Items will be measured at Baseline, 8 weeks, and 6 months; assessing a change in loneliness from baseline to 8 weeks and 6 months

Study Arms (1)

Community Exercise Program

OTHER

Participation in Health Class including: Arthritis Exercise Foundation Exercise Class, Tai Chi for Arthritis, EnhanceFitness Class, or Healthier Living Class.

Other: ExerciseOther: Health Class

Interventions

Community based exercise programs held 2-3 times per week

Community Exercise Program

Community based health class held 1 time per week

Community Exercise Program

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be cognitively stable and must be 50 years or older

You may not qualify if:

  • \<50 years
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Roxbury Park Community Center

Beverly Hills, California, 90212, United States

Location

Washington Irving Branch Library

Los Angeles, California, 90018, United States

Location

Pan Pacific Park

Los Angeles, California, 90036, United States

Location

People Coordinated Services- Crenshaw

Los Angeles, California, 90043, United States

Location

Poinsettia Park

Los Angeles, California, 90046, United States

Location

Will and Ariel Durant Library

Los Angeles, California, 90046, United States

Location

Virtual recruiting

Los Angeles, California, 90048, United States

Location

Yvonne B. Burke Senior & Community Center

Los Angeles, California, 90056, United States

Location

West Hollywood Park Auditorium

West Hollywood, California, 90069, United States

Location

MeSH Terms

Conditions

Social Isolation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Allison Mays, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR
  • Sonja Rosen, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pre-post study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2018

First Posted

August 9, 2018

Study Start

June 1, 2018

Primary Completion

June 30, 2021

Study Completion

December 31, 2023

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations