Condition category
Not Applicable
Date applied
23/02/2009
Date assigned
16/03/2009
Last edited
12/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ff100.de

Contact information

Type

Scientific

Primary contact

Prof Heinz Mechling

ORCID ID

Contact details

German Sport University Cologne
Institute of Sport Gerontology
Am Sportpark Muengersdorf 6
Cologne
50933
Germany
+49 221 4982 6148
mechling@dshs-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G 24-64-V42A-2534 (01.06.05-31.05.07); G 24-64-V42A-2947 (01.06.07-29.02.08)

Study information

Scientific title

Multi-level development and evaluation of a preventive strength training programme in residential care: an interventional single-arm multi-centre trial

Acronym

ff100 (fit for 100 [fit für 100])

Study hypothesis

Introduction
There is scientific evidence that preventive physical exercise is effective even in high age. The present study focuses on the application and implementation of this knowledge for very aged people living in residential care.

Steps of realisation
1. To conceptualise a scholarly based strength and balance training programme targeting on very old persons endangered by, or actually in, need of care
2. To conduct this programme for the purpose of research and for developing sustainable good practice models.
3. To initiate broad diffusion and establishment of the program in institutions providing geriatric care.

Conceptual framework
1. Different levels of issues and interventions are playing roles, when preventive training in residential care is to be developed and implemented:
a. Individual-social level
b. Organisational-institutional level
c. Political-cultural level

2. Consequently, these levels are also considered in the evaluation of the programme. The evaluation is based on the RE-AIM framework (Glasgow, 2002), including the dimensions Reach, Efficacy/effectiveness, Adoption, Implementation and Maintenance (RE-AIM).

Ethics approval

Ethics Committee of the German Sports University Cologne, approved on 12/01/2009.

Study design

Interventional single-arm multi-centre trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Residential geriatric care, frailty, dementia

Intervention

This is a multi-centre study with one year of interventions on multiple levels and four accompanying points of measurement, and a 12 month follow-up.

1. Individual level: Exercises 2 x 60 min training every week over one year, in group sessions (8-12 persons per group).
1.1. The principal part contains ten resistance exercises, covering the main muscle groups
1.2. One to two sets with 10 repetitions (weights can be increased now and then), one minute pauses between sets and exercises
1.3. Sensorimotor and communicative group exercises and games during the opening and closing phases of each group session
1.4. Alternative exercise for persons with no ability to stand

2. Institutional level: Sustainable implementation of training groups:
2.1. Demonstrative and motivating start by instructors belonging to the project
2.2. Training of institutional staff, who stepwise takes over the group
2.3. Supervision and coaching by project staff
2.4. Continuing information of the management and director of the institution, discussion on conditions and possibilities to resume training group after the end of the project

3. Political-cultural level:
3.1. Informing and convincing activities in professional, administrative and governmental contexts (institutionalised meetings and committees, specialised conferences, fairs)
3.2. Public relation activities (press, TV, internet)
3.3. Publication of a manual for implementing new training groups, organisation of a conference
3.4. Establishing an advisory council with renowned experts and public figures

Contact for Scientific Queries:
Dr Michael Brach
University Muenster
Institute of Sport Science
Horstmarer Landweg 62b
48149 Muenster
Germany
Tel: +49 251 83-32326
Fax: +49 251 83-32303
Email: michael.brach@wwu.de

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Individual level:
1. Continuous documentation (every session) of individual participation and individual dumb bell and ankle weights

Institutional level:
2. Number of groups continued without external financial support:
2.1. After the end of the project
2.2. After one year (follow up)

Secondary outcome measures

1. Individual level: Data collection at four times (in the beginning and every 16 weeks):
1.1. Sensorimotor tests:
1.1.1. Timed soda pop test (turning beverage cans)
1.1.2. Five timed chair stands
1.1.3. Ten-second semi tandem balance stand
1.1.4. Rotational flexibility and shoulder flexibility
1.1.5. Grip strength
1.2. Care related assessment:
1.2.1. Subjective well-being
1.2.2. Mini mental state examination (MMSE)
1.2.3. Barthel index
1.2.4. Instrumental activities of daily living (IADL)
2. Institutional and political-cultural level: Qualitative outcome description after 12 months by quantitative and qualitative analysis of media response and structured interviews with stakeholders

Overall trial start date

01/06/2005

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Political-cultural level:
1. Different administrative districts must be represented
2. Pre-selection of five regions by the Seniors' Agency of North-Rhine Westphalia

Institutional level:
1. Each geriatric residence found in the preselected regions was included in a 3-stage selection and negotiation process
2. Selection criteria focused on general professional quality and readiness for a commitment to the project, in order to raise the probability of gaining sustainable models of good practice

Individual level:
1. Participants (men and women above 80 years of age) should be able to stand with assistance and to understand instructions.
2. Group integration of a small number of persons with no ability to stand (alternative exercises) or with orientation disorders (additional assistant) is possible
3. Participation of own volition
4. Doctor's approval

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

9 institutions (72-108 participants)

Participant exclusion criteria

Institutional level:
1. Rate of educated nurses lower than 55%
2. Less than 60 ambulating residents
3. No staff to guide residents to/from the exercises
4. No staff to take part in the project training
5. Not enough room for regular group exercise

Individual level:
1. Residents not able to take part in a group activity
2. Refusal for medical condition

Recruitment start date

01/06/2005

Recruitment end date

31/05/2008

Locations

Countries of recruitment

Germany

Trial participating centre

German Sport University Cologne
Cologne
50933
Germany

Sponsor information

Organisation

Institute of Sport Gerontology (Germany)

Sponsor details

German Sport University Cologne
Am Sportpark Muengersdorf 6
Cologne
50933
Germany
+49 221 4982 6149
s.henrichs@dshs-koeln.de

Sponsor type

University/education

Website

http://www.ibusg.de

Funders

Funder type

Government

Funder name

Ministry of Work, Health and Social Affairs of the state North-Rhine Westphalia (Germany) (ref: G 24-64-V42A-2534 [01/06/05-31/05/07]; G 24-64-V42A-2947 [01/06/07-29/02/08])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

German Sport University Cologne (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Bonn (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Seniors' Agency of North-Rhine Westphalia (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

State Sport Federation of North-Rhine Westphalia (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes