An interventional study of iLiFE and gLiFE in Fall Prevention and Exercise, sponsored by Heidelberg University. Completed at 2 sites in Germany. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by Heidelberg University · Not applicable, Interventional, and Prevention
Among 222 studies in Motor Activity with a site in Germany — 40 open to participants now, 48 under way, 1 of them phase 3. Motor Activity · Germany.
Among the 222 studies in Motor Activity with a site in Germany, this one is the 29th largest by enrollment of the 192 interventional ones that give a count, is one of 13 that started in 2018, is one of 139 with no phase, and was the 119th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →40 of the 222 studies in Motor Activity with a site in Germany are open now. Recruiting first, the newest first:
German Diabetes Center · Sites in Germany
Universität Duisburg-Essen · Sites in Germany
University Medicine Greifswald · Sites in Germany
Wageningen University · Sites in Germany, Netherlands, Poland
University Hospital Schleswig-Holstein · Sites in Germany
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 70 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
222 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 21 · Phase 3 26 · Phase 4 6
First in 1998; this study’s year is marked. 13 started in 2018.
This study's enrollment of 310 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 88 across the 192 interventional studies, 147 across the 30 observational. Of the 142 that completed or were terminated, 8 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 222 have an industry lead sponsor. The 10 most frequent:
Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.
Heidelberg University has 8 studies filed under Motor Activity — fewer than ten, so there is no comparison to draw.
16 of the studies in Motor Activity with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06806059Ludwig-Maximilians - University of MunichPreoperative Physical Activity Before Radical Cystectomy and the Impact on Morbidity | 2026-11-29 |
| NCT07466173University of UlmThe Importance of Insulin Action in the Brain for the Immune System During Physical Activity-Overweight | 2026-12 |
| NCT06898684Aron OnerupMedulloblastoma Online Video-based Exercise Pilot Study | 2026-12 |
| NCT06768918Zealand University HospitalDigitizing Cancer Rehabilitation During and After Systemic Treatment: Feasibility Testing Implementation in South Baltic Countries | 2026-12-31 |
| NCT06039787University Hospital TuebingenExercise Training on Brain Insulin Responsiveness | 2026-12-31 |
Among the 222 studies in Motor Activity with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
In the Lifestyle-Integrated Functional Exercise (LiFE) program, exercises to increase strength and improve balance are embedded into daily life activities. Recurring daily activities and tasks are used as prompts for these exercises so that they are performed multiple times per day. However, implementing the original LiFE program includes high financial requirements and human resources as it comprises one-to-one supervision of participants. Therefore, it is investigated whether implementing LiFE in groups (gLiFE) is not inferior to the individually delivered LiFE (iLiFE) in terms of reducing falls per physical activity. In addition, gLiFE is expected to be more cost-effective as compared to iLiFE. In a multicenter non-inferiority trial, 300 participants aged 70 years or older with confirmed fall risk will be randomized into either the iLiFE or gLiFE arm of the study. Both arms will undergo the same strength and balance exercises and habitualization strategies as described in the LiFE program, however, based on different approaches of delivery (i.e., group vs. individual).
The "Lifestyle-integrated Functional Exercise" (LiFE) program aims to promote safe indoor and outdoor mobility. It differs from classical exercise programs in that it trains and encourages participants to embed up to 15 balance and strength exercises into daily recurring tasks performed as part of the daily life routine. The LiFE program simultaneously aims at preventing falls and promoting an active lifestyle in older adults. As LiFE requires 1:1 supervision by trainers who administer LiFE exercises during seven visits in the participants' homes, it is both time consuming and resource intensive and therefore not suitable for widespread implementation. Hence, the aim of this study is to compare a group-delivered LiFE intervention (gLiFE) with the original LiFE intervention (iLiFE). More specifically, gLiFE is tested for its non-inferiority compared to iLiFE in terms of:
In a multicenter non-inferiority trial, participants (n = 300; > 70 years; confirmed fall or high risk of falling) will be randomized into either the individual iLiFE (seven home visits) or gLiFE (groups up to twelve persons; seven group sessions).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Medical conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In iLiFE, LiFE activities to increase strength, improve balance, and promote physical activity as well as habitualization strategies are introduced and taught in 7 highly individualized, one-to-one home visits.
Behavioral: iLiFE
In gLiFE, the same LiFE activities as performed in iLiFE are introduced and taught in 7 group sessions with 8 to 12 participants. Implementation and habitualization strategies will be addressed within the group setting, making use of group dynamics and processes.
Behavioral: gLiFE
In the individual LiFE (iLiFE), the program is taught in seven visits in the individuals' homes within eleven weeks. Participants are supervised in a face to face situation by one qualified trainer (physiotherapist or sports scientist). Each home visit takes between 1 and 1.5 hours. A total of five balance exercises, seven strength exercises for the lower extremities, and two exercises to increase physical activity are taught. In addition to the home visits, all participants receive two 'booster telephone calls' within the remaining weeks until the 6-month follow-up assessments.
The group-based LiFE (gLiFE) program consists of seven group sessions (n = 8-12 participants) which are held over the course of eleven weeks, with a maximum duration of 2 hours per session. Each session is led by two qualified trainers (physio therapists or sports scientists), i.e., one main and one co-trainer. In all group sessions, trainers will teach the participants how to perform and integrate the LiFE program, i.e., LiFE balance and strength activities into their daily routines. After the group sessions have ended, participants will receive two 'booster telephone calls' within the remaining weeks until the 6-month follow-up assessments.
Fall incidence expressed as number of falls per amount of physical activity
Falls are assessed using a fall calendar; Physical activity is assessed using activPAL accelerometers
Time frame: Change; baseline, 6 months, 12 months
Cost-effectiveness of iLiFE and gLiFE
Incremental Cost-Effectiveness Ratios (ICERs) of delivering iLiFE and gLiFE
Time frame: Change; baseline, 6 months, 12 months
Accelerometer-collected physical activity (duration)
Duration of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors
Time frame: Change; baseline, 6 months, 12 months
Accelerometer-collected physical activity (percentage)
Percentage of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors
Time frame: Change; baseline, 6 months, 12 months
Accelerometer-collected physical activity (intensity)
Intensity of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors
Time frame: Change; baseline, 6 months, 12 months
Adherence to LiFE activities
Exercise Adherence Rating Scale (EARS) filled out every month in a calendar
Time frame: Monthly; starting from first iLiFE or gLiFE participation until the date of the 12 month follow-up
Self-reported function and disability
Late-Life Function and Disability Instrument (LLFDI)
Time frame: Change; baseline, 6 months, 12 months
Static balance (a)
8 Level Balance Scale
Time frame: Change; baseline, 6 months, 12 months
Static balance (b)
Instrumented Tandem Stance
Time frame: Change; baseline, 6 months, 12 months
Gait speed
instrumented walking test (4m and 7m walk at usual and fast pace)
Time frame: Change; baseline, 6 months, 12 months
Functional leg strength (a)
Instrumented 30 second Chair Stand
Time frame: Change; baseline, 6 months, 12 months
Functional leg strength (b)
Instrumented Timed Up-and-Go
Time frame: Change; baseline, 6 months, 12 months
Handgrip strength
JAMAR dynamometer
Time frame: Change; baseline, 6 months, 12 months
Cognitive status
Montreal Cognitive Assessment Tool (MoCA)
Time frame: Change; baseline, 6 months, 12 months
Balance confidence
Activities-specific Balance Confidence Scale (ABC-Scale)
Time frame: Change; baseline, 6 months, 12 months
Fear of falling
Short Falls Efficacy Scale-International (Short FES-I)
Time frame: Change; baseline, 6 months, 12 months
Health status (a)
EQ-5D-5L
Time frame: Change; baseline, 6 months, 12 months
Health status (b)
EQ-VAS
Time frame: Change; baseline, 6 months, 12 months
Health-related resource use
questionnaire for the use of medical and non-medical services in old age (FIMA)
Time frame: Change; baseline, 6 months, 12 months
Depressive Symptoms
10 Item Center for Epidemiological Studies - Depression (CES-D-10)
Time frame: Change; baseline, 6 months, 12 months
Subjective age
Subjectively felt age in years
Time frame: Change; baseline, 6 months, 12 months
Habit strength
Self-Report Behavioural Automaticity Index (SRBAI)
Time frame: Change; baseline, 6 months, 12 months
Motivational quality
Behavioural Regulation in Exercise Questionnaire (BRE-Q-3)
Time frame: Change; baseline, 12 months
Health Action Process Approach (HAPA) - Int
Intention (2 items, 6-point Likert scale)
Time frame: Change; baseline, 6 months, 12 months
Health Action Process Approach (HAPA) - SE
Self-efficacy (6 items, 6-point Likert scale)
Time frame: Change; baseline, 6 months, 12 months
Health Action Process Approach (HAPA) - ACP
Action and coping planning (6 items, 6-point Likert scale)
Time frame: Change; baseline, 6 months, 12 months
Health Action Process Approach (HAPA) - IAC
Individual action control (3 items, 6-point Likert scale)
Time frame: Change; baseline, 6 months, 12 months
Social support
Loneliness Scale
Time frame: Change; baseline, 6 months, 12 months
Group cohesion
Kohäsion im Team von Freizeit- und Gesundheitssportgruppen Scale (German)
Time frame: Change; baseline, 6 months, 12 months
Evaluation of the LiFE program
10 questions regarding quality and acceptance of as well as satisfaction with the program (6-point Likert scale)
Time frame: Change; after the last intervention session, 6 months, 12 months
Ran from Apr 2018 to primary completion in Aug 2020, 28 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 28 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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