RECRUITING

Improving Physical Activity With Cognitive Impairment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Individuals with mild cognitive impairment are often physically inactive and at risk for progressing to dementia. Physical inactivity is considered a modifiable risk factor for dementia. Therefore, interventions must be developed to foster sustainable improvement in daily physical activity. To address this problem, our pilot study aims are directed at assessing the feasibility and preliminary improvement of physical activity following the use of a mobile-health technology physical activity behavior change intervention. Similar interventions have shown to be very effective in older adults without cognitive impairment. We specifically focus on the subtype of amnestic mild cognitive impairment since this subtype often progresses to Alzheimer's Disease, a leading cause of death in the US. Improving physical activity is one approach to reduce the progression to Alzheimer's Disease and subsequently lower mortality. To increase the impact of the intervention, participants with amnestic mild cognitive impairment will be recruited along with a primary caregiver (dyads). Thirty dyads will be recruited and randomized to either an intervention group (15 dyads) or usual care group (15 dyads). The intervention group will receive a 12-week mobile-health technology physical activity behavior change intervention structured to improve physical activity. The intervention is unique in the combination of established behavior change theories and techniques and remote delivery for individuals with amnestic mild cognitive impairment. This pilot study is designed to assess the feasibility of the intervention by examining participant and primary caregiver retention, intervention session attendance, intervention acceptability and safety, and qualitative perspectives. Secondly, this pilot study will assess preliminary improvement in physical activity (i.e., daily steps). Improvement will be determined based on significant changes in participants' daily steps observed via accelerometry post-intervention in the intervention group compared to the usual care control group. The results of this study will support future work (K-award and R01 submissions) to explore efficacy and larger-scale implementation to reach rural and underserved areas of Nebraska and beyond.

Official Title

Improving Physical Activity With Cognitive Impairment

Quick Facts

Study Start:2023-02-01
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05370118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 50-85 years old (patient); 19+ years (caregiver)
  2. 2. clinically diagnosed with amnestic MCI (patient only)
  3. 3. a score of 18-24 on the Montreal Cognitive Assessment indicating possible MCI (patient only),
  4. 4. not currently categorized as "Active" on the Rapid Assessment of Physical Activity, (patient only)
  5. 5. on stable doses of medication at least for the previous 30 days at baseline (patient only)
  6. 6. have a computer/wireless device with Internet access
  7. 7. have a primary caregiver willing to participate in physical activity and assist the patient with participation in the study
  8. 8. English-speaking
  1. 1. limitations due to disability, illness, or pain that may affect the patient's walking safety during the study
  2. 2. unstable heart conditions (e.g., unstable angina, acute pericarditis)
  3. 3. uncontrolled hypertension in the last six months
  4. 4. known neurological diseases

Contacts and Locations

Study Contact

Rashelle Hoffman, PT, DPT, PhD
CONTACT
402-280-5691
rashellehoffman@creighton.edu

Study Locations (Sites)

Creighton University
Omaha, Nebraska, 68178
United States

Collaborators and Investigators

Sponsor: Creighton University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • physical activity
  • behavior change

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment
  • Caregiver Burnout