Development, implementation and evaluation of a technology-based fall prevention program for community-dwelling older adults
Organizational Data
- DRKS-ID:
- DRKS00025897
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2021-08-16
- Last update in DRKS:
- 2023-09-25
- Registration type:
- Prospective
Acronym/abbreviation of the study
For more balance and muscle strength
URL of the study
No Entry
Brief summary in lay language
This study investigates the effects of a novel technology-based fall prevention program and a following home exercise program to reduce the individual fall risk of elderly people at risk of falling. For this purpose, a novel training device ("hunova") of the company Movendo Technology is used to determine the fall risk of the subjects. Based on the subjects fall risk, an individual fall prevention program is developed. The fall prevention programm aims to reduce the fall rate and fall risks through balance and strength exercises. During the training intervention, the difficulty of the exercises will be increased. In addition, the feasibility, user experience and satisfaction of the fall prevention programs will be investigated.
Brief summary in scientific language
The primary outcome of this randomized controlled trial (RCT) is to investigate the effects of a technology-based fall prevention program and a following home exercise program with older people at risk of falling on the number of falls and number of fallers. Therefore, a novel technology-based training device ("hunova") from Movendo Technology is used, which includes balance and strength exercises. During the training intervention, the difficulty of the exercises will be increased. Secondary outcomes are fall-releated risk factors (Silver Index, Subindexes, Timed-up-and-go). Additionally, the feasibility (training diary, TLX, USE, UEQ, feedback questionnaires) of the fall prevention programs will be investigated. The study design refers to a longitudinal design with four measurement time points. To ensure participation in the fall prevention programs, exclusion criteria were defined with regard to physical constitution and acute and chronic diseases.
Health condition or problem studied
- Free text:
- Fall prevention
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Longitudinal design with four measurement time points: T0 before the start of the technology-based fall prevention program, T1 after the end of the technology-based fall prevention program with the hunova device, T2 after the end of the home training program, T3 follow-up measurement, 12 months after T2. In total, the training period of the intervention group consists of 2*24 training sessions with a training frequency of two planned training sessions (à 30 minutes) per week. The intervention period of the technology-based fall prevention program depends on the progress of the completed 24 training sessions. Due to the defined training frequency of two training sessions per week, there is a minimum of 12 weeks of the technology-based fall prevention program. If training sessions are cancelled, the intervention period is limited to a maximum of 16 weeks. Identical to the intervention period of the technology-based fall prevention program, the period of the home training program is then defined individually for each subject.
- Arm 2:
- Longitudinal design with four measurement time points: Subjects in the control group will receive the identical measurements: T0 before the start of the study, T1 after 16 weeks of T0, T2 after 16 weeks of T1, T3 follow-up measurement after 12 months of T2. Subjects in the control group are not provided with any interventions. They are supposed to maintain their usual activities. At the end of the study, the subjects of the control group will be invited to the Hunova training, which will be finalized based on the study results.
Endpoints
- Primary outcome:
- Primary outcomes are the effects of a new technology-based fall prevention program and following home training program with community dwelling older people at risk of falling on the number of falls and the number of fallers.
- Secondary outcome:
- Seconday outcomes refer to the effects on fall-related risk factors (Silver Index, subindexes, number of deficient training areas, timed-up-and-go). Additionally, the feasibility of fall prevention programs will be examined with questionnaires (feedback questionnaires, Task Load Index, Usefulness, Satisfaction and Ease of Use, User Experience Questionnaire, training diary).
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Other Therapiezentrum Düsseldorf, Köln, Bonn, Bremen
Recruitment period and number of participants
- Planned study start date:
- 2021-09-01
- Actual study start date:
- 2021-09-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 235
- Final Sample Size:
- 293
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 65 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Community-dwelling older people aged 65 years and older, who are able to walk a distance of more than 6 meters without aids, will be included in the study. Furthermore, an increased risk of falling (Silver Index > 40%) is defined as an inclusion criterion, which is determined by the hunova device (Silver Index, parameter for measuring the risk of falling).
Exclusion Criteria
In order to ensure participation in the fall prevention programs exclusion criteria were defined with regard to physical constitution and acute and chronic diseases. The exclusion criteria are checked with health questionnaires before the first measurement (see appendix).
Addresses
Primary Sponsor
- Address:
- Generali Health Solutions GmbHHansaring 40-5050670 KölnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Deutsche Sporthochschule Köln, Institut für Bewegungs- und SportgerontologieDr. Tobias MoratAm Sportpark Müngersdorf 650933 KölnGermany
- Telephone:
- 0221 4982 6129
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Deutsche Sporthochschule Köln, Institut für Bewegungs- und SportgerontologieInstitut für Bewegungs- und Sportgerontologie -Am Sportpark Müngersdorf 650933 KölnGermany
- Telephone:
- 0221 4982 6149
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Deutsche Sporthochschule Köln, Institut für Bewegungs- und SportgerontologieDr. Tobias MoratAm Sportpark Müngersdorf 650933 KölnGermany
- Telephone:
- 0221 4982 6129
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Generali Health Solutions GmbHHansaring 40-5050670 KölnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Deutschen Sporthochschule KölnAm Sportpark Müngersdorf 650933 KölnGermany
- Telephone:
- (+49)221-49823810
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-06-26
- Ethics committee number:
- 104/2021
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-07-13
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?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Gesundheitsfragebogen
- Study abstract:
- No Entry
- Other study documents:
- Morat, T.; Synders, M.; Kroeber, P.; De Luca, A.; Squeri, V.; Hochheim, M.; Ramm, P.; Breitkopf, A.; Hollmann, M.; Zijlstra, W. (2023). Evaluation of a novel technology‑supported fall prevention intervention – study protocol of a multi‑centre randomised controlled trial in older adults at increased risk of falls. BMC Geriatrics (2023) 23:103
- 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