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Adverse Events in Mobility‐Limited and Chronically Ill Elderly Adults Participating in an Exercise Intervention Study Supported by General Practitioner Practices
Author(s) -
Hinrichs Timo,
Bücker Bettina,
Wilm Stefan,
KlaaßenMielke Renate,
Brach Michael,
Platen Petra,
Moschny Anna
Publication year - 2015
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1111/jgs.13253
Subject(s) - medicine , randomized controlled trial , physical therapy , psychological intervention , adverse effect , intervention (counseling) , population , nursing , environmental health
Objectives 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 ). Design Randomized controlled trial. Setting General practitioner practices and participant homes. Participants Community‐dwelling, chronically ill, mobility‐limited individuals aged 70 and older (mean 80 ± 5) participating in a RCT of an exercise program ( HOME fit; ISRCTN 17727272) (N = 209; n = 106 experimental, n = 103 control; 74% female). Intervention 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. Measurements Adverse events were documented at least at every counseling session and assessed by the GP and an AE manager. Results One hundred fifty‐one AE s 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). Conclusion Even though the program appears to be safe, high morbidity unrelated to exercise can constitute a critical challenge for sustained exercise participation.