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

Physical Activity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412123
• Other study ID #: 01GL1705A
• Status: Completed
• Phase: N/A
• First received: January 11, 2018
• Last updated: March 10, 2018
• Start date: January 2, 2018
• Est. completion date: March 5, 2018

Study information

• Verified date: March 2018
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall Prevention
• Physical Activity

Intervention

Behavioral:
• group 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.

Locations

Country	Name	City	State
Germany	Heidelberg University, Network Aging Research	Heidelberg

Sponsors (5)

Lead Sponsor	Collaborator
Heidelberg University	German Federal Ministry of Education and Research, Robert Bosch Gesellschaft für Medizinische Forschung mbH, Universitätsklinikum Hamburg-Eppendorf, University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence of the participants to LiFE activities	Measured using the Exercise Adherence Rating Scale (EARS)	Change from the first of 7 intervention sessions (i.e., at week 1) at the end of the intervention period (i.e., week 7)
Primary	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)	at the end of the intervention period (i.e., week 7)
Primary	Participants' views on the gLiFE program	Participants' views on: planning and engaging in gLiFE activities; the gLiFE manual; support from the trainers; their ideas for improving the program; the group format	at the end of the intervention period (i.e., week 7)
Secondary	Functional performance	Timed up-and-go test (measured in seconds; shorter time represents better performance)	Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)
Secondary	Motor performance (balance)	8 Level balance scale (measured in accomplished levels; higher level represents better performance)	Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)
Secondary	Motor performance (strength)	5-chair rise (measured in seconds; shorter time represents better performance)	Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)

External Links

•   Project website as part of the overall working group's website
•   Website of the overall LiFE-is-LiFE trial