NCT05476614

Brief Summary

Research demonstrates that yoga is beneficial for the older adults with or nearing mild cognitive impairment. Social robots are increasingly being used as companions and caregivers for older adults with or nearing MCI . The purpose of this study is to test the efficacy of social robot-led yoga for older adults with or nearing MCI. The study hypothesizes that social robot-led yoga is similar in effectiveness to human-led yoga across a range of measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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

May 15, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

May 15, 2022

Last Update Submit

February 27, 2024

Conditions

Testing the Efficacy of Social Robot-led Yoga

Keywords

yogamindfulnessrobot

Outcome Measures

Primary Outcomes (8)

  • Overhead flexion range of motion

    Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.

    At Week 0

  • Overhead flexion range of motion

    Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.

    At Week 6

  • Overhead flexion range of motion

    Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.

    At Week 12

  • Overhead flexion range of motion

    Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.

    At Week 18

  • Single-leg balance hold duration

    Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.

    At Week 0

  • Single-leg balance hold duration

    Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.

    At Week 6

  • Single-leg balance hold duration

    Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.

    At Week 12

  • Single-leg balance hold duration

    Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.

    At Week 18

Secondary Outcomes (12)

  • Kentucky Inventory of Mindfulness Skills (KIMS)

    At Week 0

  • Kentucky Inventory of Mindfulness Skills (KIMS)

    At Week 6

  • Kentucky Inventory of Mindfulness Skills (KIMS)

    At Week 12

  • Kentucky Inventory of Mindfulness Skills (KIMS)

    At Week 18

  • The Patient Health Questionnaire (PHQ-9)

    At Week 0

  • +7 more secondary outcomes

Study Arms (2)

Social robot-instructed yoga group

EXPERIMENTAL

A socially assistive robot will be programmed to instruct 10-14 yoga postures for a group of 20-25 older adults. The yoga session will also include meditation and centering exercises.

Other: Yoga (Robot-instructed)

Human-instructed yoga group

ACTIVE COMPARATOR

A human yoga instructor will lead 10-14 yoga postures for a group of 20-25 older adults. The yoga session will also include meditation and centering exercises.

Other: Yoga (Human-instructed)

Interventions

Yoga (Robot-instructed)OTHER

Yoga that is instructed by a social robot

Social robot-instructed yoga group
Yoga (Human-instructed)OTHER

Yoga that is instructed by a human

Human-instructed yoga group

Eligibility Criteria

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

You may qualify if:

  • Age 65 years or older.
  • SLUMS score of 20-26 will include persons with moderate cognitive impairment
  • SLUMS score of \>26 will include persons without moderate cognitive impairment
  • Verbal skill to interact
  • Available for a period of 12 weeks to participate in yoga
  • Ability to stand without supports

You may not qualify if:

  • Age younger than 65 years
  • Aggressive behaviors
  • Medical diagnosis of dementia or memory loss
  • An inability to balance on a single leg without supports
  • Acute physical illness that impairs or precludes physical activity
  • SLUMS score equal to or below 20, the cutoff for dementia
  • A drop in SLUMS score greater than 3 points from the beginning of the study to the midpoint of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Denver

Denver, Colorado, 80210, United States

Location

Related Publications (3)

  • Brenes GA, Sohl S, Wells RE, Befus D, Campos CL, Danhauer SC. The Effects of Yoga on Patients with Mild Cognitive Impairment and Dementia: A Scoping Review. Am J Geriatr Psychiatry. 2019 Feb;27(2):188-197. doi: 10.1016/j.jagp.2018.10.013. Epub 2018 Oct 25.

    PMID: 30413292BACKGROUND

  • Kachouie, R., Sedighadeli, S., Khosla, R., & Chu, M. T. (2014). Socially assistive robots in elderly care: a mixed-method systematic literature review. International Journal of Human-Computer Interaction, 30(5), 369-393.

    BACKGROUND

  • Fan JT, Chen KM. Using silver yoga exercises to promote physical and mental health of elders with dementia in long-term care facilities. Int Psychogeriatr. 2011 Oct;23(8):1222-30. doi: 10.1017/S1041610211000287. Epub 2011 Mar 9.

    PMID: 21385519BACKGROUND

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Sean Mapoles, MS

    University of Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be grouped at random into social robot-instructed yoga or human-instructed yoga.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2022

First Posted

July 27, 2022

Study Start

August 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

US(1)