Telerehabilitation Physical Activity for Mild Cognitive Impairment

Overseen By Rashelle Hoffman, PT, DPT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Creighton University

Disqualifiers: Disability, Unstable heart, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been on stable doses of medication for at least the previous 30 days before starting the study.

What data supports the effectiveness of the treatment Telerehabilitation Physical Activity Behavioral (TPAB) intervention for Mild Cognitive Impairment?

Research shows that telerehabilitation programs, like the GOAL Tele-R system, are feasible and well-received by patients with Mild Cognitive Impairment (MCI), with high adherence rates and positive feedback on cognitive, emotional, and physical benefits. This suggests that such programs can effectively engage patients in activities that may help prevent further cognitive decline. ^{1 2 3 4 5}

Is telerehabilitation physical activity safe for humans?

Research on telerehabilitation physical activity, including for conditions like mild cognitive impairment and stroke, suggests it is generally safe when proper safety measures are in place, such as monitoring by therapists and ensuring participants are familiar with the technology used. ^{1 3 6 7 8}

How is the Telerehabilitation Physical Activity Behavioral (TPAB) intervention different from other treatments for mild cognitive impairment?

The TPAB intervention is unique because it uses technology like smartphones and videoconferencing to deliver physical activity programs remotely, allowing patients to engage in rehabilitation from home. This approach is particularly beneficial for older adults with mild cognitive impairment, as it provides a convenient and supportive way to improve their quality of life without needing to travel to a clinic. ^{1 3 9 10 11}

Eligibility Criteria

This trial is for pairs of individuals where one person has mild cognitive impairment (MCI) aged between 50-85, and their caregiver who is over 19. The patient should have a diagnosis of amnestic MCI, score within a specific range on a cognitive assessment test, not be very physically active, and be stable on medications. Both must speak English and have internet access.

Inclusion Criteria

Have a computer/wireless device with Internet access

I have been diagnosed with memory loss that affects my daily life.

A score of 18-24 on the Montreal Cognitive Assessment indicating possible MCI (patient only)

Exclusion Criteria

I have health issues that could make walking unsafe for me during the study.

I have a diagnosed neurological condition.

My blood pressure has been stable for the last six months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week mobile-health technology physical activity behavior change intervention

12 weeks

12 weekly sessions (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Telerehabilitation physical activity behavioral (TPAB) intervention

Trial Overview The study tests a Telerehabilitation physical activity behavioral intervention using mobile-health technology to improve daily physical activity in patients with MCI. Thirty pairs will either receive this 12-week intervention or usual care to see if it's feasible and effective at increasing steps measured by accelerometry.

Participant Groups

Group I: Telerehabilitation physical activity behavioral (TPAB) intervention Experimental Treatment 1 Intervention

Individuals in the TPAB intervention will participate in a weekly session for 12 weeks with their primary caregiver and the research interventionist (RH). Established behavior-change techniques will be used in the TPAB intervention, based largely on the combination of the Social Cognitive Theory, Control Theory, and Operant Conditioning,43 including behavioral techniques, and patient-centered communication (e.g., motivational interviewing).44 The behavior-change techniques are designed to target and improve daily steps. Individuals in the CTL group will receive usual care and no intervention over the 12 weeks.

Group II: Control Group Active Control 1 Intervention

Individuals in the CTL group will receive usual care and no intervention over the 12 weeks.

Who Is Running the Clinical Trial?

Creighton University

Lead Sponsor

Trials

128

Recruited

25,800+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The GOAL Tele-R system demonstrated good feasibility and adherence among patients with Mild Cognitive Impairment (MCI) and Vascular Cognitive Impairment (VCI), with an overall adherence rate of 84% to the proposed activities.

Patients using the Tele-R system had significantly lower drop-out rates compared to those receiving standard care (34% vs. 62%), and participants reported high satisfaction levels, indicating that technology-based rehabilitation can be effective and well-received in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Feasibility, Adherence, and Appreciation of a Newly Developed Tele-Rehabilitation Program for People With MCI and VCI. Mosca, IE., Salvadori, E., Gerli, F., et al.[2023]

Physical activity (PA) interventions for individuals with mild traumatic brain injury (mTBI) can improve various health-related outcomes, suggesting that incorporating PA into rehabilitation programs is beneficial.

The review identified 35 articles and 14 gray literature records, highlighting a need for higher-quality research and better reporting on intervention details to enhance the effectiveness and replicability of these PA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Interventions for Individuals With a Mild Traumatic Brain Injury:: A Scoping Review. Alarie, C., Gagnon, I., Quilico, E., et al.[2023]

Home-based telerehabilitation exercise programs using videoconferencing and activity tracking devices were found to be feasible for individuals with moderate to severe traumatic brain injury (TBI), with high adherence and satisfaction reported by participants and their family partners.

The study suggests that telerehabilitation can enhance access to physiotherapy for TBI patients, allowing them to focus on therapy rather than travel, although further research is needed to evaluate its effectiveness on physical outcomes like balance and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely Supervised Exercise Programmes to Improve Balance, Mobility, and Activity Among People with Moderate to Severe Traumatic Brain Injury: Description and Feasibility. O'Neil, J., Egan, M., Marshall, S., et al.[2023]

Structured telephone-based interventions for adults with traumatic brain injury (TBI) showed positive effects on global functioning, posttraumatic symptoms, sleep quality, and depressive symptoms, with 4 out of 5 randomized controlled trials reporting significant improvements.

While the feasibility of Internet-based telerehabilitation was supported, the evidence for its efficacy remains inconclusive due to a lack of sufficient studies, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Telerehabilitation for Adults With Traumatic Brain Injury: A Systematic Review. Ownsworth, T., Arnautovska, U., Beadle, E., et al.[2019]

This study tests a new tele-rehabilitation program designed for individuals with Mild Cognitive Impairment (MCI) and Vascular Cognitive Impairment (VCI), combining cognitive, physical, and social activities over 8 weeks to help prevent cognitive decline.

Involving 60 participants in a randomized controlled trial, the program aims to assess its effectiveness in improving cognitive functioning, physical health, and quality of life compared to a control group, with evaluations at baseline, after the program, and at a 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Games for Older Adults Active Life (GOAL) Project for People With Mild Cognitive Impairment and Vascular Cognitive Impairment: A Study Protocol for a Randomized Controlled Trial. Fabbri, L., Mosca, IE., Gerli, F., et al.[2020]

A scoping review of 107 studies involving 3991 participants with stroke found that safety measures during asynchronous telerehabilitation exercises are rarely reported, with only 10 studies detailing such measures.

Common safety strategies included assessing exercise locations, using seated positions, and implementing live warning systems to prevent risky exercises, highlighting the need for more comprehensive reporting in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. Gutierrez-Arias, R., González-Mondaca, C., Marinkovic-Riffo, V., et al.[2023]

In a study of 1,087 service members and veterans with a history of mild traumatic brain injury (mTBI), no significant differences in cognitive performance were found across varying levels of aerobic physical activity, suggesting that exercise may not directly enhance cognitive function in this population.

However, individuals engaging in regular aerobic activity reported higher life satisfaction and overall health, indicating that while exercise may not improve cognitive tests, it positively impacts subjective well-being for those with chronic mTBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of Aerobic Activity to Cognition and Well-being in Chronic Mild Traumatic Brain Injury: A LIMBIC-CENC Study. Wright, BM., Zhang, C., Fisher, RR., et al.[2023]

The 8-week remote progressive walking intervention was found to be feasible, safe, and acceptable for 20 adults with persistent post-concussion symptoms, with a high adherence rate of 94.38%.

Participants significantly increased their weekly steps and reported reductions in post-concussion symptoms, kinesiophobia, anxiety, and fatigue, while also experiencing improvements in quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Remotely Delivered Progressive Walking Intervention for Adults With Persistent Symptoms of a Mild Traumatic Brain Injury: Feasibility and Exploration of Its Impact. Alarie, C., Gagnon, I., de Guise, E., et al.[2022]

Telerehabilitation shows promise in improving the quality of life for older adults with mild cognitive impairment (MCI) or cognitive frailty (CF), based on a review of six studies published between 2015 and 2020.

Despite its potential, the use of telerehabilitation for cognitive frailty is still limited, indicating a need for more research to assess its feasibility, acceptability, and the role of social support in enhancing adherence and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review for Usage of Telerehabilitation among Older Adults with Mild Cognitive Impairment or Cognitive Frailty. Md Fadzil, NH., Shahar, S., Rajikan, R., et al.[2022]

A telerehabilitation program for patients with multi-domain amnestic Mild Cognitive Impairment (md-aMCI) showed significant improvements in cognitive performance, particularly in delayed and working memory, language skills, and overall cognition, after 15 weeks of intervention with 30 participants.

The study suggests that telerehabilitation can be an effective alternative to traditional face-to-face therapies, especially during challenging times like the pandemic, providing hope for stabilizing cognitive decline in md-aMCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy and Feasibility of a Telerehabilitation Program Using Language and Cognitive Exercises in Multi-Domain Amnestic Mild Cognitive Impairment. Nousia, A., Pappa, E., Siokas, V., et al.[2023]

Home-based telerehabilitation for elderly individuals in Southeast Asia shows equal or better effects on physical function compared to traditional rehabilitation methods, based on a systematic review of six studies.

The average completion rate for these telerehabilitation interventions was 81%, indicating good feasibility for implementation, although the studies had a high risk of bias and varied in participant health conditions and intervention types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and feasibility of home-based telerehabilitation for community-dwelling elderly people in Southeast Asian countries and regions: a systematic review. Saito, T., Izawa, KP.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of Feasibility, Adherence, and Appreciation of a Newly Developed Tele-Rehabilitation Program for People With MCI and VCI. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Physical Activity Interventions for Individuals With a Mild Traumatic Brain Injury:: A Scoping Review. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Remotely Supervised Exercise Programmes to Improve Balance, Mobility, and Activity Among People with Moderate to Severe Traumatic Brain Injury: Description and Feasibility. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Telerehabilitation for Adults With Traumatic Brain Injury: A Systematic Review. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Games for Older Adults Active Life (GOAL) Project for People With Mild Cognitive Impairment and Vascular Cognitive Impairment: A Study Protocol for a Randomized Controlled Trial. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Relation of Aerobic Activity to Cognition and Well-being in Chronic Mild Traumatic Brain Injury: A LIMBIC-CENC Study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Remotely Delivered Progressive Walking Intervention for Adults With Persistent Symptoms of a Mild Traumatic Brain Injury: Feasibility and Exploration of Its Impact. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Scoping Review for Usage of Telerehabilitation among Older Adults with Mild Cognitive Impairment or Cognitive Frailty. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy and Feasibility of a Telerehabilitation Program Using Language and Cognitive Exercises in Multi-Domain Amnestic Mild Cognitive Impairment. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness and feasibility of home-based telerehabilitation for community-dwelling elderly people in Southeast Asian countries and regions: a systematic review. [2021]