NCT07171255

Brief Summary

Alzheimer's disease and related dementias are a public health crisis impacting individuals across the world. In the United States, adults living in rural areas face an elevated risk for cognitive impairment mainly due to disparities in care, higher sedentary behavior, and reduced education. This project proposes to assess the impact of a remotely delivered exercise program (i.e., RemoteEx+) through a smartphone application. The app is programmed by our team and provides video demonstrations of exercises, workout regimes, motivational messaging, and weekly ADRD risk reduction education. The project aims to assess with a pre/post design the following aims:

  • Aim 1. Assess the RemoteEx+ intervention exercise adherence, efficacy, enjoyment, and quality of life. We hypothesize that rural adults will report high exercise adherence (80% of session adherence), efficacy (\>50% on Self Efficacy for Exercise), and enjoyment (\>5.0 on Intrinsic Motivation Inventory - Interest / Enjoyment Subscale) and that these variables will be positively correlated with quality of life scores (36-Item Short Form Health Survey \[SF-36\])
  • Aim 2. Determine the impact of a technology-driven exercise program on blood pressure and functional mobility associated with dementia risk. We hypothesize that the exercise program will result in improvements in blood pressure and functional mobility (2-minute step test and 30-second chair rise test) and that participants with high exercise adherence will see the greatest improvements in biomarkers associated with reduced dementia risk.
  • Aim 3. Reduce health disparities among rural-dwelling Nebraska and Kansas residents. We hypothesize that RemoteEx+ will reduce barriers to exercise (Barriers to Being Active Quiz and improve knowledge surrounding dementia and modifiable risk factors (Dementia Knowledge Assessment Tool - Version 2 \[DKAT2\]) that will result in fewer lifestyle-related health disparities for the communities involved in this study. The results from this project will inform whether RemoteEx+ has an impact on the stated outcomes above for adults living in rural areas.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress83%
Aug 2025Jun 2026

Study Start

First participant enrolled

August 22, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

September 12, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

August 26, 2025

Last Update Submit

September 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    Baseline and Week 16

Secondary Outcomes (7)

  • Cardiovascular Endurance

    Baseline and Week 16

  • Lower Extremity Strength

    Baseline and Week 16

  • Exercise Adherence

    Baseline and Week 16

  • Exercise Efficacy

    Baseline and Week 16

  • Quality of Life Improvement

    Baseline and Week 16

  • +2 more secondary outcomes

Study Arms (1)

RemoteEx+ Program

EXPERIMENTAL
Behavioral: RemoteEx+ Programming

Interventions

The exercise program will include video instruction for all exercises, motivational cues, and ADRD risk education throughout the 16-week exercise program to encourage exercise adherence. RemoteEx+ is optimized to enhance exercise knowledge surrounding dementia risk factors to facilitate ADRD risk reduction and overall health improvement. The purpose of this study is to investigate the efficacy of RemoteEx+ on health outcomes associated with dementia risk in underactive rural adults.

RemoteEx+ Program

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-85 years
  • Characterized as underactive by the Telephone Assessment of Physical Activity (TAPA)50
  • Self-reported proficiency in English
  • Own a smartphone and willing to download an application
  • Primary care provider clearance to participate for those who do not pass the PAR-Q+51
  • Live in a rural area (Rural-Urban Commuting Area \[RUCA\] Codes) 52

You may not qualify if:

  • Contraindications to high-intensity exercise
  • Cognitive impairment (\<19 on the Telephone Montreal Cognitive Assessment \[MoCA\])
  • Neurodegenerative or acute neurological diagnoses (e.g., Parkinson's disease, stroke, traumatic brain injury)
  • Orthopedic surgery or injuries in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emporia State University

Emporia, Kansas, 66801, United States

RECRUITING

Creighton University

Omaha, Nebraska, 68178, United States

RECRUITING

Central Study Contacts

Rashelle Hoffman, PT, DPT, PhD

CONTACT

Erin Blocker, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 12, 2025

Study Start

August 22, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

September 12, 2025

Record last verified: 2025-04

Locations