Cognitive Training while Seated to Reduce Motor Risk Factors of Falls in Older Adults at Increased Risk of Falling: A Randomized and Controlled Pilot Study
Organizational Data
- DRKS-ID:
- DRKS00033333
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2024-02-29
- Last update in DRKS:
- 2024-02-29
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Mobility performances, such as walking, are complex and require the integration of sensory, mental, and motor processes. These processes and their interplay determine the fall risk in older individuals. Falls are the primary reason for injuries in the elderly and a significant cause of loss of independence and decreased quality of life. One-third of people over 65 fall at least once a year. There is solid evidence showing the efficacy of structured physical training in reducing fall risk. However, the extent to which mental (seated) training influences fall risk and mobility is unclear. This randomized and controlled study investigates the effect of cognitive training on mobility and fall risk in older adults. Participants (N=20) with a moderate risk of falling will train for 12 weeks using an app, specifically targeting higher mental functions, attention, and processing speed. The control group (N=20) will maintain their usual activities and will have the opportunity to undergo the intervention after the initial 12 weeks (waitlist control group). Various assessments, considered as validated markers for the fall risk of older people, will be conducted before and after the intervention.
Brief summary in scientific language
Balance control and walking ability are crucial for an individual's mobility. As existing evidence shows, these abilities are linked with higher cognitive processes (executive functions). This is particularly true in situations with increased or simultaneous motor-cognitive demands. Brain functions such as working memory, attentional and inhibitory control, as well as the speed of information processing, act as regulators for motor processes. A decline in these cognitive domains is associated with an increased likelihood of mobility impairments and falls in older adults. The planned pilot study will examine whether a purely cognitive training program can have positive effects on the mobility and fall risk of older adults at increased risk of falling. N=40 older individuals will be randomized into intervention and control groups. The intervention group will undergo specific cognitive training associated with mobility, balance control, and fall risk while seated using an app. The training will be conducted at home for 12 weeks, three times per week for approximately 30 minutes each. Motor-cognitive, motor, and cognitive parameters will be assessed at the beginning and immediately after the intervention to investigate the efficacy of the training on these fall risk-relevant domains.
Health condition or problem studied
- Free text:
- accidental falls, fall-related injuries
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- - home-based computerized, cognitive training while seated for 12 weeks, 3 sessions/week, 30 minutes/session - training will be administered via App (NeuroNation MED) on tablet computers or smartphones - cognitive training comprises of game-based tasks on processing speed, attention, executive functions - training tasks progress based on participant performance
- Arm 2:
- - waitlist control group - maintains normal activities - receives an evidence-based brochure on falls and fall prevention - receives access to the intervention after 12 weeks
Endpoints
- Primary outcome:
- Inhibitory choice stepping reaction time (iCSRT; Schoene, Delbaere & Lord, 2017, J Am Med Dir Assoc) at 12 weeks
- Secondary outcome:
- motor-cognitive performance at 12 weeks - Trail-walking test (Schott, 2015, Z Gerontol Geriatr), - Multi-target stepping test (Yamada, 2011, J Gerontol A Biol Sci Med Sci) - Dual-task 10-meter walk test - Dual-task Timed Up-and-Go Test motor performance at 12 weeks - 10-meter walk test - Timed up-and-Go Test (TUG), - static balance test, - De Morton Mobility Index (DEMMI) cognitive performance at 12 weeks using a computerized test battery - Simple reaction time test - Choice reaction time test - Digit symbol substitution test - Visual search test - Trail making test - Go/No-Go tapping test - Mental rotation
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Einrichtungen des Betreuten Wohnens Kommune (Leipzig Stadt und Umland)
Recruitment period and number of participants
- Planned study start date:
- 2024-03-18
- Actual study start date:
- No Entry
- Planned study completion date:
- 2024-08-30
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 40
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 65 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - ability to walk 10 meters independently (with or without a walking aid) - moderate to high risk of falling (a fall in the past year or concerns about falling or feeling unsteady while walking and standing AND Timed-Up & Go (TUG) test time >12 seconds or Short Physical Performance Battery (SPPB) score <9 or habitual walking speed <0.8 m/s). - access to a tablet or smartphone and the ability to use it
Exclusion Criteria
- Neurodegenerative diseases - sensory deficits that impair participation (e.g., severe hearing or vision impairment) - regular participation in physical or cognitive training
Addresses
Primary Sponsor
- Address:
- Professur für Gesundheits- und RehabilitationssportDr. Heike StreicherJahnallee 5904109 LeipzigGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.spowi.uni-leipzig.de/gesundheitssport-und-public-health
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Professur für Gesundheits- und RehabilitationssportPhD Daniel SchöneJahnallee 5904109 LeipzigGermany
- Telephone:
- +49 1575 195 0797
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Professur für Gesundheits- und RehabilitationssportPhD Daniel SchöneJahnallee 5904109 LeipzigGermany
- Telephone:
- +49 1575 195 0797
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Professur für Gesundheits- und RehabilitationssportPhD Daniel SchöneJahnallee 5904109 LeipzigGermany
- Telephone:
- +49 1575 195 0797
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Professur für Gesundheits- und Rehabilitationssport04109 LeipzigGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikbeirat Universität LeipzigRitterstraße 2604109 LeipzigGermany
- Telephone:
- +49 341 97-34996
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-leipzig.de/forschung/forschungsservice/ethikbeirat
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-11-18
- Ethics committee number:
- 2023.11.18_eb_227
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-12-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Individual participant data that underlie the results reported in an article will be shared after deidentification and after approval of a methodologically sound proposal sent to hstreich@uni-leipzig.de up to 5 years following an article's publication. Data requestors will need to sign a data-sharing agreement.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry