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

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT03412123
Collaborator
Robert Bosch Gesellschaft für Medizinische Forschung mbH (Other), University of Ulm (Other), Universitätsklinikum Hamburg-Eppendorf (Other), German Federal Ministry of Education and Research (Other)
6
Enrollment
1
Location
1
Arm
2
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: group lifestyle-integrated functional exercise
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 2, 2018
Actual Primary Completion Date :
Mar 5, 2018
Actual Study Completion Date :
Mar 5, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adherence of the participants to LiFE activities [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)

  2. Evaluation of the intervention and its components [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)

  3. Participants' views on the gLiFE program [at the end of the intervention period (i.e., week 7)]

    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

Secondary Outcome Measures

  1. Functional performance [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)

  2. 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)

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Heidelberg University, Network Aging Research Heidelberg Germany 69115

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Carl-Philipp Jansen, Post-Doctoral Research Assistant, Heidelberg University
ClinicalTrials.gov Identifier:
NCT03412123
Other Study ID Numbers:
  • 01GL1705A
First Posted:
Jan 26, 2018
Last Update Posted:
Mar 13, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 13, 2018