NCT03716037

Brief Summary

The proposed research effort will: The purpose of this study is as follows:

  1. 1.Test the feasibility and acceptability of an eight-week community-based exercise program among AA older adults living in rural areas.
  2. 2.Determine whether participation in physical exercise through a community-based exercise program in comparison with an attentional control group: a) improves physical well-being b) improves psychosocial well-being

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
2.9 years until next milestone

Study Start

First participant enrolled

September 22, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

October 11, 2018

Last Update Submit

May 26, 2024

Conditions

Keywords

physical activityexercisedepressionanxietystress

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the community based exercise program as measured by enrollment rate

    enrollment rate which is the number of participants who sign the informed consent form divided by the number who are approached should be ≥ 60%

    12 months

Secondary Outcomes (7)

  • physical activity as measured by Fitbit trackers

    12 months

  • psychosocial Well-being as measured by the Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health Measure-10

    12 months

  • Satisfaction Outcome as measured by the Client satisfaction Questionnaire

    12 months

  • Physical Function as measured by the senior fitness test

    12 months

  • physical activity as measured by Fitbit trackers

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Physical Activity

EXPERIMENTAL

Physical Activity for Life (PAL) is an 8-week exercise program, meeting three times per week for one hour sessions.

Other: Physical Activity for Life (PAL)

Contact Control

NO INTERVENTION

those in the attentional contact control group will receive a phone call from research personnel three times per week asking them about their physical exercise routines.

Interventions

The eight-week exercise program (The PAL Study) will incorporate balance, strength, endurance, and flexibility training. The duration of each exercise session, which will be offered three times a week, will be one hour. The supervised exercise session will include 30 minutes of moderate-intensity aerobic exercise, 15 minutes of resistance training, and 15 minutes of stretching and balance training

Physical Activity

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • At least 65 years of age
  • Identifying as AA
  • community dwelling and living in a rural community.
  • Sedentary life style (engaging in less than two hours of structured physical exercises whether independently or in a group setting every week)
  • Identify as having altered psychosocial health by scoring at least a 10 on the Patient Health Questionnaire (PHQ-9), which is indicative of moderate depressive symptoms (Kroenke, Spitzer, \& Williams, 2001).

You may not qualify if:

  • \. cognitive impairment as defined by the St. Louis University Mental Status Exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniontown Recreation Center

Uniontown, Alabama, 36786, United States

Location

MeSH Terms

Conditions

Motor ActivityDepressionAnxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorBehavioral SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mercy N Mumba, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 23, 2018

Study Start

September 22, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations