title: Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices.
abstract: OBJECTIVE
  To present detailed adverse event (AE) data from a randomized controlled trial (RCT) of a home-based exercise program delivered to an elderly high-risk population by an exercise therapist after medical clearance from a general practitioner (GP).
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  General practitioner practices and participant homes.
  
  
  METHODS
  Community-dwelling, chronically ill, mobility-limited individuals aged 70 and older (mean 80 ± 5) participating in a RCT of an exercise program (HOMEfit; ISRCTN17727272) (N = 209; n = 106 experimental, n = 103 control; 74% female).
  
  
  METHODS
  A 12-week multidimensional home-based exercise program (experimental) versus baseline physical activity counseling (control). An exercise therapist delivered both interventions to participants during counseling sessions at the GP's practice and on the telephone.
  
  
  METHODS
  Adverse events were documented at least at every counseling session and assessed by the GP and an AE manager.
  
  
  RESULTS
  One hundred fifty-one AEs were reported in 47% (n = 99) of all participants. Twenty-one (14%) events were classified as serious. In six events (4%; n = 4 experimental, n = 2 control), participation in the study had to be discontinued immediately. In 25 events (17%; n = 9 experimental, n = 16 control), the intervention had to be suspended. The intervention was determined to have caused two events (both nonserious and in the experimental group).
  
  
  CONCLUSIONS
  Even though the program appears to be safe, high morbidity unrelated to exercise can constitute a critical challenge for sustained exercise participation.
authors: Swiss Paraplegic Research, Nottwil, Switzerland; Department of Sports Medicine and Sports Nutrition, Ruhr University Bochum, Bochum, Germany; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne, Switzerland.
authors: Timo
authors: T
authors: Hinrichs
authors: Bettina
authors: B
authors: Bücker
authors: Stefan
authors: S
authors: Wilm
authors: Renate
authors: R
authors: Klaaßen-Mielke
authors: Michael
authors: M
authors: Brach
authors: Petra
authors: P
authors: Platen
authors: Anna
authors: A
authors: Moschny
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D037001:Directive Counseling; D005081:Exercise Therapy / Q000009:adverse effects*; D005260:Female; D058006:General Practice; D006699:Home Care Services; D006801:Humans; D008297:Male; D051346:Mobility Limitation; D010349:Patient Compliance
keywords: aged; chronic disease; exercise; general practice; mobility limitation; safety