Activity in old age [Aktivität im Alter]

Completed

• Conditions: Aged, physical inactivity, chronic disease, mobility restriction; Musculoskeletal Diseases

• Registration Number: ISRCTN17727272
• Lead Sponsor: Ruhr-University Bochum (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-19
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy endpoints (after 12 weeks of intervention):<br>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)<br>2. Physical activity (step count)<br>3. Health-related quality of life (Short Form-8 Health Survey)<br>4. Fall related self-efficacy (Falls Efficacy Scale-International Version)<br>5. Exercise self-efficacy (SSA-Scale)<br><br>Further measures:<br>1. Patient compliance<br>2. Appraisal by participants<br>3. Appraisal by GPs<br>4. Appraisal by exercise therapists<br>5. (Serious) adverse events<br>6. Reasons for discontinued intervention