Feasibility of a Novel Exergame-Based Training Concept for Older Adults With Mild Neurocognitive Disorder

NCT04996654 | Completed

• 1 other identifier: EK 2021-N-79
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this pilot study is to evaluate the feasibility (i.e. recruitment, adherence, compliance, attrition), usability (i.e. system usability), and acceptance (i.e. enjoyment, training motivation and perceived usefulness) of a newly developed exergame-based intervention concept for older adults with mNCD. As a secondary objective, preliminary effects of the intervention on cognition, brain resting-state functional connectivity, gait, cardiac autonomic regulation, and psychosocial factors (i.e. quality of life, and levels of depression, anxiety, and stress) will be explored. This allows to synthesize data for a sample size calculation on basis of a formal power calculation for a future RCT. A two-arm, parallel-group, single-blinded (i.e. outcome evaluator of pre- and post-measurements blinded to group allocation) pilot randomized controlled study with an allocation ration of 2 : 1 (i.e. intervention : control) including 17 - 25 older adults with mNCD will be conducted between June and December 2021. The active control group will proceed with usual care as provided by the memory clinics where the patients are recruited. The intervention group will perform a twelve-week training intervention according to a newly developed exergame-based intervention concept in addition to usual care. Primary outcomes will be assessed throughout the training intervention period. The measurements of all secondary outcomes will be conducted at ETH Hönggerberg within two weeks prior to starting (PRE) and after completing (POST) the study intervention.

Conditions

Mild Neurocognitive Disorder

Keywords

Exergames; Mild Neurocognitive Disorder; Cognition; Feasibility; Usability

Outcome Measures

Primary Outcomes (9)

• Feasibility - recruitment (relative)

  recruitment rate (relative) \[%\] = number of screened people / number of enrolled participants

  Through recruitment completion, an average of 12 weeks.

• Feasibility - recruitment (absolute)

  recruitment rate (absolute) \[\] = number of eligible participants recruited per month

  Through recruitment completion, an average of 12 weeks.

• Feasibility - adherence

  adherence rate \[%\] = total number of training sessions attended / total number of training sessions offered

  Through recruitment completion, an average of 12 weeks.

• Feasibility - compliance

  compliance rate \[%\] = total training duration attended \[min\] / total training duration offered \[min\]

  Through recruitment completion, an average of 12 weeks.

• Feasibility - attrition

  attrition rate = number of drop-outs / number of enrolled participants

  Through recruitment completion, an average of 12 weeks.

• Usability

  Usability will be assessed on basis of the validated German version of the System Usability Scale (SUS-DE). The SUS-DE is assessed in week 6 of the exergame-based intervention. It consists of ten items that are rated on a five-point Likert scale (i.e. ranging from 1 - "strongly disagree" to 5 - "strongly agree"). A total score will be calculated according to the scoring guidelines of the SUS. The total SUS score ranges between 0 and 100, whereas higher scores indicate better usability. A total SUS score of at least 70 will be considered an "acceptable" solution (i.e. 52 = ok, 73 = good, 85 = excellent, 100 = best imaginable).

  System Usability is assessed in the Exergame Group at week 6 of the study intervention.

• Acceptance - enjoyment

  Enjoyment of the exergame-based intervention concept will be assessed on basis of the Exergame Enjoyment Questionnaire (EEQ) that will be translated to German according to the guidelines for the process of cross-cultural adaptation of self-report measures. It consists of 20 statements corresponding to four categories of questions: (1) immersion, (2) intrinsically rewarding activity, (3) control, and (4) exercise. Each statement will be responded to on a five-point Likert scale (i.e. strongly disagree (1 point), disagree (2 points), neutral (3 points), agree (4 points), and strongly agree (5 points). The EEQ will be analyzed by calculating the average overall score as well as an average score for each category of questions.

  Through recruitment completion, an average of 12 weeks.

• Acceptance - motivation

  The quality (of type) and quantity (of level) of training motivation will be assessed using of the German version of the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3) that is a widely used, valid and reliable measure of the continuum of motivation for exercise in different areas. It consists of 24 items assessing behavioral regulation in exercise contexts on a 5- point Likert scale ranging from 0 = 'not true for me' to 4 = 'very true for me'.

  Through recruitment completion, an average of 12 weeks.

• Acceptance - perceived usefulness

  Perceived usefulness will be evaluated on basis of patient-interviews, organized as semi-structured interviews along a predefined interview guide.

  Through recruitment completion, an average of 12 weeks.

Secondary Outcomes (16)

• Changes in Global Cognition

  Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.

• Changes in Learning and Memory - Part 1

  Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.

• Changes in Learning and Memory - Part 2

  Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.

• Changes in Complex Attention - Part 1

  Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.

• Changes in Complex Attention - Part 2

  Both, the pre- and the post-measurements of secondary outcome measurements will take place and within two weeks prior to starting or after completing the intervention.

Study Arms (2)

Exergame

EXPERIMENTAL

Participants will perform a twelve-week training intervention in addition to their usual care as provided by the memory clinics where the patients are recruited. The training intervention will be prescribed according to a newly developed exergame-based intervention concept that consists of an individually adapted multi-domain exergame-based simultaneous cognitive-motor training with incorporated cognitive tasks that will be adopted with a deficit-oriented focus on the neurocognitive domains of (1) learning and memory, (2) executive function, (3) complex attention, and (4) perceptual-motor function.

Behavioral: Exergame

Usual Care

ACTIVE COMPARATOR

An active control group will proceed with usual care as provided by the memory clinics where the patients are recruited.

Behavioral: Usual Care

Interventions

Exergame BEHAVIORAL

According to the training concept, each participant is instructed to train 5x/week for 21 min per session resulting in a weekly exercise volume of 105 min. All training sessions are planned to take place at participant's homes using the exergame training system Dividat Senso (Dividat AG, Schindellegi, Switzerland; CE certification).

Exergame

Usual Care BEHAVIORAL

An active control group will proceed with usual care as provided by the memory clinics where the patients are recruited.

Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (Group 1 = mNCD) clinical diagnosis of 'Mild Neurocognitive Disorder' (mNCD) according to the International Classification of Diseases 11th Revision (ICD-XI) OR (Group 2 = sMCI) patients screened for mild cognitive impairment (sMCI) according to the following criteria: (a) informant (i.e. healthcare professionals)-based suspicion of MCI confirmed by (b) an objective screening of MCI based on the German Version of the Quick Mild Cognitive Impairment Screen with (b1) a recommended cut-off score for cognitive impairment (MCI or dementia) of \< 62/100, while (b2) not falling below the cut-off score for dementia (i.e. \< 45/100), while (c) activities of daily living remain intact.
• fully vaccinated against coronavirus (SARS-CoV-2) with a Federal Office of Public Health (FOPH)-approved mRNA vaccine
• German speaking
• age ≥ 50 years
• able to stand at least for 10 min without assistance

You may not qualify if:

• mobility impairments (i.e. gait, balance) that prevent experiment participation
• presence of additional neurological disorders (i.e. epilepsy, stroke, multiple sclerosis, Parkinson's disease, brain tumors, or traumatic disorders of the nervous system)
• presence of any other unstable or uncontrolled diseases
• high blood pressure (self-reported; systolic ≥ 140 mmHg and/or Diastolic ≥ 90 mmHg)
• Chronic respiratory condition
• Diabetes
• Condition or therapy that weakens the immune system
• Cardiovascular Disease
• Cancer (present and/or under treatment)
• Serious obesity (BMI ≥ 40 kg/m2)

Sponsors & Collaborators

• Eling DeBruin: lead

Study Sites (1)

ETH Zurich

Zurich, 8093, Switzerland

Location

Related Publications (1)

• Manser P, Poikonen H, de Bruin ED. Feasibility, usability, and acceptance of "Brain-IT"-A newly developed exergame-based training concept for the secondary prevention of mild neurocognitive disorder: a pilot randomized controlled trial. Front Aging Neurosci. 2023 Sep 21;15:1163388. doi: 10.3389/fnagi.2023.1163388. eCollection 2023.

  PMID: 37810620 RESULT

MeSH Terms

Conditions

Neurocognitive Disorders

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eling D de Bruin, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome evaluator of the pre- and post-measurements will be blinded to group allocation. For all data assessed throughout the intervention period (i.e. only applicable for the intervention group), blinding of investigators is not possible. Blinding of participants was also not possible since usual care will be used as a control intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Allocation ration = 2 (Exergame Group) : 1 (Usual Care)

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: August 9, 2021
• Study Start: July 12, 2021
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

CH (1)