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Trial record 2 of 2 for:    life-is-life

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03412123
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
University of Ulm
Universitätsklinikum Hamburg-Eppendorf
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Carl-Philipp Jansen, Heidelberg University

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
Fall Prevention Physical Activity Behavioral: group lifestyle-integrated functional exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2, 2018
Actual Primary Completion Date : March 5, 2018
Actual Study Completion Date : March 5, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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:

    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


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412123


Locations
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Germany
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
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Principal Investigator: Michael Schwenk, PhD Heidelberg University
Study Chair: Clemens Becker, MD Robert Bosch Medizinische Gesellschaft mbH
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carl-Philipp Jansen, Post-Doctoral Research Assistant, Heidelberg University
ClinicalTrials.gov Identifier: NCT03412123    
Other Study ID Numbers: 01GL1705A
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No