Condition category
Musculoskeletal Diseases
Date applied
19/08/2011
Date assigned
19/09/2011
Last edited
28/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Exercise programmes are used to treat patients with a number of chronic diseases and help to improve mobility and physical functioning in older adults. Until now, such programmes targeted either healthy community-dwelling seniors or elderly people living in special residences or care institutions. Chronically ill or mobility restricted people, however, are difficult to reach when they live in their own homes. We have evaluated a new home-based exercise programme, delivered to the participant by an exercise therapist in counselling sessions in the GP’s practice and on the telephone. The aim of this study is to evaluate the effects of the exercise programme on patients’ physical function, physical activity and quality of life.

Who can participate?
Community-dwelling, chronically ill and mobility restricted patients, aged 70 or over, who visit their GP’s practice.

What does the study involve?
Eligible patients will be invited for an assessment in the GP’s practice and randomly allocated to one of two groups. One group will undergo the new home-based exercise programme, delivered by an exercise therapist in counselling sessions in the GP’s practice and on the telephone. The other group will attend counselling sessions promoting physical activities such as light intensity walking.

What are the possible benefits and risks of participating?
Increasing physical activity may initially increase the risk of injuries compared to a sedentary lifestyle. However, in the long term, an increase in physical activity is considered to lead to an improvement in gait and mobility and a reduction of fall and injury risk. For the patients who are eligible for the study, the expected cardiovascular benefit of the programme exceeds the risk for adverse cardiovascular events. To reduce the risk of adverse events, the exercise programme is tailored to the patient’s abilities by an exercise therapist (in cooperation with the GP).

Where is the study run from?
Study management and overall coordination are performed by the Department of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Germany. The study will take place at about 15 GP practices around the city of Bochum, Germany.

When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study between December 2011 and March 2013, so that the last participant is expected to finish the intervention in June 2013.

Who is funding the study?
The study is funded by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]).

Who is the main contact?
Dr Timo Hinrichs
timo.hinrichs@rub.de

Trial website

http://www.ruhr-uni-bochum.de/homefit/

Contact information

Type

Scientific

Primary contact

Dr Timo Hinrichs

ORCID ID

Contact details

Ruhr-University Bochum
Department of Sports Medicine and Sports Nutrition
Overbergstr. 19
Bochum
44801
Germany
+49 (0)234 3229166
timo.hinrichs@rub.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01ET1005A

Study information

Scientific title

Effects of an exercise programme for chronically ill and mobility restricted elderly with structured support given by the general practitioner's practice (HOMEfit) - a randomized controlled trial

[Effekte eines Bewegungsprogramms für chronisch kranke und mobilitätseingeschränkte Ältere mit strukturierter Unterstützung durch die hausärztliche Praxis (HOMEfit) - ene randomisierte kontrollierte Studie]

Acronym

HOMEfit

Study hypothesis

The objective of this trial is to evaluate the effects of a new multidimensional home-based exercise programme for chronically ill and mobility restricted elderly with structured support given by the general practitioner's (GP) practice on physical function, physical activity, health-related quality of life, fall-related self-efficacy, and exercise self-efficacy.

Main hypothesis:
The new programme (experimental intervention) is more effective in increasing functional lower body strength (measured by a timed test of 5 sit-to-stand cycles [chair rising test]) than the control intervention after 12 weeks.

Follow up study to http://www.isrctn.com/ISRCTN58562962

Ethics approval

University Witten/Herdecke Ethics Committee, 15/08/2011, ref: 77/2011

Study design

Randomized controlled multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Aged, physical inactivity, chronic disease, mobility restriction

Intervention

The duration of the intervention is 12 weeks.
The experimental intervention has been designed according to state-of-the-art physical activity recommendations for older adults (ACSM/AHA 2007). It consists of:
1. Multidimensional (strength, endurance, balance, flexibility) home-based exercise integrating preventive and therapeutic recommendations
2. Consultations provided by an exercise therapist (in the GP's practice and via telephone) including attention, instruction, and methods fostering behavioural change.

The control intervention promotes baseline physical activities, and thus consists of:
1. Baseline activities of daily life, e.g. light-intensity walking
2. Consultations provided by an exercise therapist (in the GP's practice and via telephone) including attention and instruction.

Details of the experimental intervention have already been published in the study protocol of the feasibility study (see Publications). Some modifications have been performed to the programme as a result of quantitative and qualitative analyses.

For all participants, additional medical treatment is permitted before and during the trial except ongoing rehabilitation measures following an inpatient surgical procedure (see exclusion criteria).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Primary efficacy endpoint (after 12 weeks of intervention):
Functional lower body strength measured by the chair rising test (timed test of 5 sit-to-stand cycles)

Secondary outcome measures

Secondary efficacy endpoints (after 12 weeks of intervention):
1. Physical functioning (battery of motor tests: timed up and go, 2-minute step-in-place, tandem stand, tandem walk, grip strength, chair sit-and-reach)
2. Physical activity (step count)
3. Health-related quality of life (Short Form-8 Health Survey)
4. Fall related self-efficacy (Falls Efficacy Scale-International Version)
5. Exercise self-efficacy (SSA-Scale)

Further measures:
1. Patient compliance
2. Appraisal by participants
3. Appraisal by GPs
4. Appraisal by exercise therapists
5. (Serious) adverse events
6. Reasons for discontinued intervention

Overall trial start date

01/12/2011

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Community-dwelling (not institutionalized) primary care patient
2. Age 70 years or above, either gender
3. Diagnosed with at least one of the following diseases:
3.1. Arterial hypertension
3.2. Diabetes mellitus type 2
3.3. Coronary heart disease
3.4. Chronic heart failure
3.5. Peripheral arterial disease
3.6. Chronic obstructive lung disease
3.7. Renal insufficiency
3.8. Degenerative spine disease
3.9. Hip or knee osteoarthritis
3.10. Osteoporosis with or without pathologic fracture
4. Mobility limitation defined by self-report of at least some difficulties in either walking 2 km or climbing one flight of stairs
5. Ability to at least walk short distances within rooms with or without a walking aid; but without the help of another person
6. Ability to visit the GP's practice for repeated consultations
7. Medical clearance from the GP to participate in the study
8. Ability to cooperate appropriately and to follow the instructions of the home-based exercise programme
9. Written informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

210 (recruited in about 15 general practices)

Participant exclusion criteria

1. Inability to attend or complete the proposed course of intervention and follow-up (including not having a telephone or being unable to have telephone conversations)
2. Spouses of participants, persons living in the same household and former participants of the feasibility trial
3. Inability to perform the 'chair rising test' (primary outcome)
4. Regular performance of exercises, sporting activities or leisure activities that cause sweating and/or harder breathing for 2 hours or more per week; or walking outdoors for 4 hours or more per week
5. Untreated arterial hypertension or significantly elevated blood pressure despite antihypertensive medication (GP's judgement)
6. Higher grade chronic heart failure (NYHA grade III–IV)
7. Higher grade chronic obstructive pulmonary disease (GOLD grade IV)
8. Acute psychiatric disorder (e.g. severe depression)
9. Severe consuming illness
10. Clinically relevant cardiovascular event within past 3 months
11. Clinically relevant cerebrovascular event within past 3 months
12. Deterioration of insufficiently controlled diabetes mellitus (according to GP's judgement) within past 3 months, or HbA1c exceeding 10% (if available)
13. Ongoing rehabilitation measures following an inpatient surgical procedure
14. Concurrent participation in another clinical trial

Recruitment start date

01/12/2011

Recruitment end date

30/06/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Ruhr-University Bochum
Bochum
44801
Germany

Sponsor information

Organisation

Ruhr-University Bochum (Germany)

Sponsor details

c/o Prof Petra Platen
Department of Sports Medicine and Sports Nutrition
Overbergstr. 19
Bochum
44801
Germany
+49 (0)234 3224099
petra.platen@rub.de

Sponsor type

University/education

Website

http://www.ruhr-uni-bochum.de

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Funder name

Department of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Germany

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Medical Informatics, Biometry and Epidemiology, Ruhr-University Bochum, Germany

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute of General Practice and Family Medicine, University Witten/Herdecke, Germany

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute of Sport and Exercise Science, University of Muenster, 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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22188781
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24317380
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25688602
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27676362

Publication citations

  1. Protocol

    Hinrichs T, Moschny A, Brach M, Wilm S, Klaaßen-Mielke R, Trampisch M, Platen P, Effects of an exercise programme for chronically ill and mobility-restricted elderly with structured support by the general practitioner's practice (HOMEfit) - study protocol of a randomised controlled trial., Trials, 2011, 12, 263, doi: 10.1186/1745-6215-12-263.

  2. Results

    Brach M, Moschny A, Bücker B, Klaaßen-Mielke R, Trampisch M, Wilm S, Platen P, Hinrichs T, Recruiting hard-to-reach subjects for exercise interventions: a multi-centre and multi-stage approach targeting general practitioners and their community-dwelling and mobility-limited patients., Int J Environ Res Public Health, 2013, 10, 12, 6611-6629, doi: 10.3390/ijerph10126611.

  3. Results

    Hinrichs T, Bücker B, Wilm S, Klaaßen-Mielke R, Brach M, Platen P, Moschny A, Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices, J Am Geriatr Soc, 2015, 63, 2, 258-269, doi: 10.1111/jgs.13253.

Additional files

Editorial Notes

28/09/2016: Publication reference added.