Clinical trial NCT03412123: Pilot of a Group-based Program on Lifestyle-integrated Functional Exercise (LiFE) in Older Persons
Official title: Feasibility of the "Lifestyle-integrated Functional Exercise" Concept Delivered in a Group (gLiFE) of Persons Above 70 Years of Age - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Prevention
Physical Activity
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: University of Ulm
name: Universitätsklinikum Hamburg-Eppendorf
name: German Federal Ministry of Education and Research
First posted: 2018-01-26
Enrollment: 6
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling
* Aged 70+

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

Primary outcomes:
measure: Adherence of the participants to LiFE activities
timeFrame: Change from the first of 7 intervention sessions (i.e., at week 1) at the end of the intervention period (i.e., week 7)
measure: Evaluation of the intervention and its components
timeFrame: at the end of the intervention period (i.e., week 7)
measure: Participants' views on the gLiFE program
timeFrame: at the end of the intervention period (i.e., week 7)
Secondary outcomes:
measure: Functional performance
timeFrame: Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)
measure: Motor performance (balance)
timeFrame: Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)
measure: Motor performance (strength)
timeFrame: Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University, Network Aging Research
Study officials:
affiliation: Heidelberg University
name: Michael Schwenk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Bosch Medizinische Gesellschaft mbH
name: Clemens Becker, MD
role: STUDY_CHAIR
References:
citation: 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.