Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study...

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).

Randomized controlled trial.

General practitioner practices and participant homes.

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).

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.

Adverse events were documented at least at every counseling session and assessed by the GP and an AE manager.

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).

Even though the program appears to be safe, high morbidity unrelated to exercise can constitute a critical challenge for sustained exercise participation.