Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices

Abstract

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 (HOMEfit; ISRCTN17727272) (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 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).

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

Keywords: aged; chronic disease; exercise; general practice; mobility limitation; safety.