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

Feasibility of the Lifestyle-integrated Functional Exercise Concept Delivered in a Group (gLiFE) of Persons Above 70 Years of Age - a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03412123
Enrollment
6
Registered
2018-01-26
Start date
2018-01-02
Completion date
2018-03-05
Last updated
2018-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall Prevention, Physical Activity

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.

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.

Sponsors

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
CollaboratorOTHER
University of Ulm
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
Heidelberg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Participants' views on the gLiFE programat the end of the intervention period (i.e., week 7)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
Adherence of the participants to LiFE activitiesChange from the first of 7 intervention sessions (i.e., at week 1) at the end of the intervention period (i.e., week 7)Measured using the Exercise Adherence Rating Scale (EARS)
Evaluation of the intervention and its componentsat the end of the intervention period (i.e., week 7)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)

Secondary

MeasureTime frameDescription
Functional performanceChange from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)Timed up-and-go test (measured in seconds; shorter time represents better performance)
Motor performance (balance)Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)8 Level balance scale (measured in accomplished levels; higher level represents better performance)
Motor performance (strength)Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)5-chair rise (measured in seconds; shorter time represents better performance)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026