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
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