Physical inactivity and multimorbidity Not Applicable Physical inactivity and multimorbidity
Conditions
Interventions
The intervention program lasts 12 weeks. It consists of physical activity counselling and a home-based multidimensional activity program that has been developed according to current recommendations on
Sponsors
Ruhr-University Bochum (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants are recruited consecutively by primary care physicians within prespecified time periods. All patients aged greater than or equal to 70 years who are seen by the physician within his consultation hours within that time period are screened for eligibility for the study. Inclusion criteria include: 1. Aged greater than or equal to 70 years, either sex 2. Medical clearance from the primary care physician to participate in the study 3. Walking ability (with or without walking aid) and ability to get to repeated consultations in the primary care physician's practice 4. Patient being able to cooperate appropriately and to follow the instructions of the home-based activity program (primary care physician's judgement) 5. Patient providing written informed consent
Exclusion criteria
Exclusion criteria: 1. Intervention doesn't fit into the patient's schedule 2. Untreated arterial hypertension or arterial hypertension despite antihypertensive medication (primary care physician's judgement) 3. Deterioration of an insufficiently controlled diabetes mellitus within the past 3 months (primary care physician's judgement) or HbA1c greater than 10% (if available) 4. Chronic heart failure New York Heart Association (NYHA) grade III - IV 5. Clinically relevant cardiovascular event within the past 3 months (e.g. unstable angina pectoris, myocardial infarction, coronary angiography/angioplasty, cardiac surgery) 6. Clinically relevant cerebrovascular event within the past 3 months (e.g. stroke, recurrent transient ischaemic attack [TIA]) 7. Acute psychiatric disorder (e.g. depression) 8. Severe consuming illness 9. Any inpatient surgical procedure within the past 3 months 10. Concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Appraisal by partaking primary care physicians (structured interview: would you participate again? Why/why not? Ideas for programme improvements?), measured after the last patient finished the study 2. Documentation of any undesirable event during the intervention (standardised report protocol: medical/non-medical; caused/not caused by exercise; subject may/may not continue exercises), measured continously during the training phase 3. Adherence and drop-out measures (drop-out conditions: medical reason, change or misjudgement of inclusion criteria, subject's own decision), measured at every contact with the patient (phone call, personal visit to the surgery, etc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effect measures, measured before and after the individual training phase: 1.1. Motor tests: Timed Up and Go Test, Chair Rising Test, Tandem Stand, Tandem Walk, grip strength, Sit-and-Reach Test 1.2. Phone interview: 8-item Short Form Health Survey (SF-8), three month recall of frequency of falls, Falls Efficacy Scale (FES-I), PRISCUS-Physical activity questionnaire 2. Evaluation by participant, measured after the individual training phase: 2.1. Utility rating scale for programme actions and devices: instruction, personal and phone consultation, exercise booklet and diary, pedometer and elastic resistance band 2.2. Structured interview on programme features: duration, frequency of phone and personal consultation, recommendation for extent and intensity of exercise 2.3. Open question: concrete proposals for program improvements 3. Evaluation of exercise execution by the exercise therapist (three point scale rating: execution is correct, is not correct but without/and possibly with harmful consequences), measured after the individual training phase 4. Focus group discussion with stakeholder representatives (investigator, exercise therapists, primary care physicians, surgery personnel, participants, drop outs), measured after the last patient finished the study | — |
Countries
Germany
Outcome results
None listed