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Completed

NCT Number: NCT03412123

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

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.

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Key information

Conditions

Fall Prevention Behavior Motor Activity Physical Activity

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heidelberg University, Network Aging Research

Heidelberg, 69115, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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)

  3. Participants' views on the gLiFE program

    Time frame: 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 outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2018
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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