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

March 10, 2018 updated by: Carl-Philipp Jansen, Heidelberg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69115
        • Heidelberg University, Network Aging Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gLiFE pilot group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence of the participants to LiFE activities
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)
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
Time Frame: at 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)
at the end of the intervention period (i.e., week 7)
Participants' views on the gLiFE program
Time Frame: at 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
at the end of the intervention period (i.e., week 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional performance
Time Frame: Change 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)
Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)
Motor performance (balance)
Time Frame: 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)
Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)
Motor performance (strength)
Time Frame: 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)
Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

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

Investigators

  • Principal Investigator: Michael Schwenk, PhD, Heidelberg University
  • Study Chair: Clemens Becker, MD, Robert Bosch Medizinische Gesellschaft mbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2018

Primary Completion (Actual)

March 5, 2018

Study Completion (Actual)

March 5, 2018

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 10, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 01GL1705A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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