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Fall PreventionNCT03412123

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

A study testing group lifestyle-integrated functional exercise in people with Fall Prevention and Physical Activity, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Fall Prevention, Physical Activity
What is being tested?
group lifestyle-integrated functional exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteGermany
Study dates
2 Jan 2018to 5 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Community-dwelling
  • Aged 70+

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Heidelberg University, Network Aging Research

    Heidelberg, 69115

Other trials in Germany

About this study

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

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.

Being tested
group lifestyle-integrated functional exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • group lifestyle-integrated functional exerciseBehavioural

    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.

Study groups in NCT03412123
Study groupRoleWhat they receive
gLiFE pilot groupExperimentalNot described
Receives: Behavioral: group lifestyle-integrated functional exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence of the participants to LiFE activities

    Measured using the Exercise Adherence Rating Scale (EARS)

    Measured: Change from the first of 7 intervention sessions (i.e., at week 1) at the end of the intervention period (i.e., week 7)

  2. 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)

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

  3. 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

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

Secondary outcomes (3)

  1. Functional performance

    Timed up-and-go test (measured in seconds; shorter time represents better performance)

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

  2. Motor performance (balance)

    8 Level balance scale (measured in accomplished levels; higher level represents better performance)

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

  3. Motor performance (strength)

    5-chair rise (measured in seconds; shorter time represents better performance)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start2 Jan 2018
  3. Primary completion5 Mar 2018
  4. Study completion5 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03412123
Sponsor's protocol ID
01GL1705A
Status last verified
Mar 2018
First submitted
11 Jan 2018
Last updated
13 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31993213

Questions about this trial

What is this clinical trial studying?

A study testing group lifestyle-integrated functional exercise in people with Fall Prevention and Physical Activity, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03412123, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.

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