NCT04203030

Brief Summary

This study is being conducted to test if a program with physical activity and learning about movement (including goal setting, benefits of physical activity, and how to increase physical activity gradually) helps people to become more active and to move better. The physical activity program involves specific exercises done in a group setting, and the education part will involve learning about different ways to move to make everyday activities easier. The program will last 16 weeks. This program will take place in a large fellowship area of a partner church through an established community-based participatory research partnership in Chicago, IL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2020

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

December 16, 2019

Last Update Submit

March 8, 2021

Conditions

Keywords

agingphysical function

Outcome Measures

Primary Outcomes (1)

  • Physical Function

    Change in Short Physical Performance Battery score Scale ranges from 0-12 (integers only) with higher scores indicating better function.

    16 weeks

Secondary Outcomes (3)

  • Physical Activity (Objective)

    16 weeks

  • Physical Activity (Self-Reported)

    16 weeks

  • Acceptability of intervention:

    16 weeks

Study Arms (1)

Physical Activity

EXPERIMENTAL

16 week physical activity intervention

Behavioral: Physical Activity

Interventions

Participants will meet in a weekly group session to discuss a topic related to physical activity and physical function and participate in group-based physical activity. Participants will also have instructions to participate in physical activity outside of the weekly sessions, incrementally increasing their total physical activity over the intervention period.

Physical Activity

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 or older
  • Not currently participating in another formal exercise program and perform less than 150 minutes per week of exercise
  • Ambulatory, defined as able to get out of a chair and walk without assistance aside from using a straight cane.
  • Have any difficulty: Walking ¼ mile, (about 2-3 blocks) OR Walking up 10 steps without resting
  • Speak English
  • Safe to begin an exercise program (determined using the Exercise Assessment and Screening for You (EASY) Tool. Physician clearance may be needed based upon EASY Screening recommendations

You may not qualify if:

  • Severe cognitive impairment, defined as five or more errors on the Short-Portable Mental Status Questionnaire
  • Plans to move out of the geographic area during the study period
  • Plans to have major surgery within the study period Anticipate having major schedule changes that would interfere with ability to participate in the program.
  • Inability to get to intervention location on a weekly basis
  • Unwilling to commit to a weekly, approximately 90 minute program for 16 weeks.
  • Contraindications to exercise determined using the EASY/healthcare follow-up.
  • Self-reported
  • Heart disease
  • Uncontrolled diabetes mellitus
  • Pacemaker
  • Stroke within past 12 months
  • Severe chronic lung disease (emphysema or COPD)
  • Recent healing or unhealed fractures in the past 6 months
  • Heart failure
  • Chronic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Preventive Medicine

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 18, 2019

Study Start

December 16, 2019

Primary Completion

September 4, 2020

Study Completion

September 4, 2020

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations