Recruiting

Walking Program

Sponsor:

Creighton University

Code:

NCT07914218

Conditions

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Interventions

Telerehabilitation Physical Activity Behavioral Intervention

Study Details

Brief summary:

The purpose of this study is to determine the practicality/feasibility of a virtual physical activity intervention to improve daily steps for Veterans with mild cognitive impairment and their care partners living in rural areas.

Participation includes:

  • Complete a 6-week walking program
  • Complete 2 testing visits (1 before and 1 after the 6-week walking program) consisting of various surveys and questionnaires
  • Complete a semi-structured interview on feasibility and feedback of the intervention
  • Potentially serve on an advisory board with the research team to assist with implementing the walking program adaptations

Conditions

Mild Cognitive Impairment (MCI)

Study ID

NCT07914218

Start date

Jun 12, 2026

Status verified date

Dec, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria for Veterans:

  • 60-95 years of age
  • Mild cognitive impairment as staged by Clinical Dementia Rating (CDR, a gold standard cognitive outcome in ADRD clinical research) score of 0.5 or equivalent
  • Characterized as underactive by the Telephone Assessment of Physical Activity (TAPA)
  • Have a care partner willing to participate in physical activity and assist the participant
  • Own a smartphone or tablet and willing to download a fitness tracker application
  • Live in a rural area according to the VA Office of Rural Health rurality calculator

Inclusion Criteria for Veterans \& Care Providers:

  • No self-reported falls in the last year
  • Able to walk across a room in the home with no assistive device(s)
  • Stable doses of medication over the previous 30 days
  • Pass the Physical Activity Readiness Questionnaire+ (answering "no" to questions are pages 1-3)
  • Interaction as a dyad (Veteran and care partner) at least on a weekly basis

Inclusion Criteria for Veterans \& Care Providers:

  • 19 years of age or older
  • No cognitive impairment as indicated by a score of < 1 on the AD8 Dementia Screening Interview

Exclusion Criteria for Veterans \& Care Providers:

  • Neurodegenerative or acute neurological diagnoses (e.g., Parkinson's disease, stroke, traumatic brain injury)

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Field Testing Group

Interventions

Telerehabilitation Physical Activity Behavioral Intervention

Six dyads (n=12) will complete TPAB field testing and will undergo testing at baseline and post-intervention. Consent, baseline testing, intervention delivery, and post-testing will be conducted virtually via Microsoft Teams and data recorded in VA REDCap. Testing sessions will not be recorded, with the exception of semi-structured interviews during post-testing. The testing procedures will take approximately 2 hours to complete at each testing time point. The TPAB intervention will involve weekly 30-minute sessions with study personnel for 6 weeks. Due to the 7-day activity monitor data collection prior to and following the 6-week TPAB intervention, participants will be enrolled in the study for approximately 8 weeks. Three dyads will be asked to join the advisory board with the research team to assist with implementing the walking program adaptations based on the collective feedback across the 16 dyads.

Primary outcome measure

  • Weekly Session Attendance [ Time Frame: From enrollment to end of the 6-week intervention ]
  • Study Retention [ Time Frame: From enrollment to end of intervention at 8 weeks ]
  • Intrinsic Motivation Inventory (IMI) [ Time Frame: Post-intervention (week 8) ]
  • Number of participants with study-related adverse events [ Time Frame: From enrollment to end of intervention at 8 weeks ]
  • Average Daily Stepping [ Time Frame: Pre (before starting the 6-week walking program) and Post Intervention (following completion of the 6-week walking program) ]
  • Qualitative Intervention Feasibility Outcomes [ Time Frame: Post-intervention (for feedback) ]

Central Contacts and Locations

Central contacts

Rashelle Hoffman, PT, DPT, PhD

402-280-5691rashellehoffman@creighton.edu

Locations

Creighton University

Recruiting

Omaha, Nebraska, United States, 68178

Contacts

Rashelle Hoffman, PT, DPT, PhD

402-280-5691rashellehoffman@creighton.edu

More Information

Sponsor

Creighton University

Last update posted

Nov 3, 2026

Last verified

Dec, 2025

Keywords

  • mild cognitive impairment
  • physical activity
  • veterans
  • walking
  • care partners
  • dyads

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Creighton University on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.