ClinicalTrials.gg
CompletedNCT03412123Updated Mar 13, 2018

Pilot of a Group-based Program on Lifestyle-integrated Functional Exercise (LiFE) in Older Persons

An interventional study of group lifestyle-integrated functional exercise in Fall Prevention and Physical Activity, sponsored by Heidelberg University. Completed at 1 site in Germany. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Heidelberg University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

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.

Enrollment
191st of 192
6 · median 88
Started
2018
with 12 others
No phase
139 of 222
33 open now
Registered
117th of 222
by date
Lead sponsor
7 of 222
Heidelberg University

Among the 222 studies in Motor Activity with a site in Germany, this one is the 191st 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 117th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

40 of the 222 studies in Motor Activity with a site in Germany are open now. Recruiting first, the newest first:

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All 40 open studies →

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 →

Who these studies take

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.

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02

Study summary

This feasibility pilot is part of the project "LiFE-is-LiFE" (2017-2020). It is based on the Lifestyle-Integrated Functional Exercise (LiFE) program by Clemson et al., which has proven effective in improving strength, balance, and physical activity while simultaneously reducing falls in older people via incorporating exercises in recurring daily tasks. However, implementing the original LiFE program includes high financial requirements and human resources. Therefore, LiFE-is-LiFE investigates whether implementing LiFE in groups (gLiFE) is not inferior to the original, individually delivered LiFE in terms of reducing falls per physical activity. In this pilot study, we evaluate our conception of gLiFE for large-scale use in the subsequent, larger LiFE-is-LiFE trial.

03

Conditions studied

  • Fall Prevention
  • Physical Activity

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04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Community-dwelling
  • Aged 70+

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment
  • Neurological condition which severely influences gait and mobility
  • Severe visual impairment
  • Inability to ambulate independently
  • Significant lung disease or chronic heart failure or any other unstable or terminal illness that would preclude the planned exercises
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    gLiFE pilot group

    Behavioral: group lifestyle-integrated functional exercise

Interventions

  • Behavioralgroup lifestyle-integrated functional exercise

    Manualized teaching of balance and strength principles and integration of exercises and physical activity into daily routine during 7 sessions in a group of 8 to 10 participants with 2 trainers. The pilot intervention group will undergo the same strength and balance exercises and learn about the same physical activity enhancement strategies as described in the LiFE programme by Clemson et al. (BMJ 2012;345:e4547). However, instead of 7 home visits, gLiFE participants will attend seven group sessions (1 session/week). In these, LiFE contents are adapted to the group setting and enhanced by health psychological and behaviour change strategies fitting to the social structure and modalities of a group.

06

What researchers measure

Primary outcomes

  1. Adherence of the participants to LiFE activities

    Measured using the Exercise Adherence Rating Scale (EARS)

    Time frame: Change from the first of 7 intervention sessions (i.e., at week 1) at the end of the intervention period (i.e., week 7)

  2. Evaluation of the intervention and its components

    Rating of helpfulness (5-point Likert scale), safety (5-point Likert scale), level of difficulty (5-point Likert scale), and adaptability (5-point Likert scale)

    Time frame: at the end of the intervention period (i.e., week 7)

  3. Participants' views on the gLiFE program

    Participants' views on: 1. planning and engaging in gLiFE activities 2. the gLiFE manual 3. support from the trainers 4. their ideas for improving the program 5. the group format

    Time frame: at the end of the intervention period (i.e., week 7)

Secondary outcomes

  1. Functional performance

    Timed up-and-go test (measured in seconds; shorter time represents better performance)

    Time frame: Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)

  2. Motor performance (balance)

    8 Level balance scale (measured in accomplished levels; higher level represents better performance)

    Time frame: Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)

  3. Motor performance (strength)

    5-chair rise (measured in seconds; shorter time represents better performance)

    Time frame: Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)

07

Study locations

1 site
  • Heidelberg University, Network Aging Research
    Heidelberg, 69115, Germany
08

References and documents

Publications

  • Kramer F, Labudek S, Jansen CP, Nerz C, Fleig L, Clemson L, Becker C, Schwenk M. Development of a conceptual framework for a group-based format of the Lifestyle-integrated Functional Exercise (gLiFE) programme and its initial feasibility testing. Pilot Feasibility Stud. 2020 Jan 22;6:6. doi: 10.1186/s40814-019-0539-x. eCollection 2020. PubMed 31993213 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Mar 2018, 2 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 2 months is below 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.

Registered
Jan 11, 2018
First posted
Jan 26, 2018
StartActual
Jan 2, 2018
Primary completionActual
Mar 5, 2018
CompletionActual
Mar 5, 2018
Last update
Mar 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03412123
Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH, University of Ulm, Universitätsklinikum Hamburg-Eppendorf, German Federal Ministry of Education and Research
Responsible party
Carl-Philipp Jansen (Post-Doctoral Research Assistant, Heidelberg University) — Principal investigator
First posted
Jan 26, 2018
Start date
Jan 2, 2018
Primary completion
Mar 5, 2018
Completion
Mar 5, 2018
Last update
Mar 13, 2018

Study contacts

Michael Schwenk, PhD
principal investigator · Heidelberg University
Clemens Becker, MD
study chair · Robert Bosch Medizinische Gesellschaft mbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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