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

NCT03412123 | Completed

• 1 other identifier: 01GL1705A
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall Prevention; Physical Activity

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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

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

Secondary Outcomes (3)

• Functional performance

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

• Motor performance (balance)

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

• Motor performance (strength)

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

Study Arms (1)

gLiFE pilot group

EXPERIMENTAL

Behavioral: group lifestyle-integrated functional exercise

Interventions

group lifestyle-integrated functional exercise BEHAVIORAL

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.

gLiFE pilot group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-dwelling
• Aged 70+

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF): collaborator
• University of Ulm: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

Heidelberg University, Network Aging Research

Heidelberg, 69115, Germany

Location

Related Publications (1)

• 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.

  PMID: 31993213 DERIVED

Related Links

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

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Michael Schwenk, PhD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

• Clemens Becker, MD

  Robert Bosch Medizinische Gesellschaft mbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Research Assistant

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 26, 2018
• Study Start: January 2, 2018
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)