Physical activity, emotional state and socialization in the elderly: study protocol for a clinical multicentre randomized trial

OBJECTIVE: To evaluate whether a 4-month physical activity (PA) group program and visits to sociocultural organizations improve emotional state, social support levels and health-related quality of life in elderly individuals with depression and/or anxiety and/or loneliness. METHODS: This will be a multicentre, randomized, two-group clinical trial with a 1-year follow-up. Participants will be 150 primary care patients aged >64 years allocated equally to a control group and an intervention group. Inclusion criteria are Beck Depression Inventory (BDI-II) score ≥14 and/or General Anxiety Disorder (GAD-7) scale score ≥10 and/or Duke-UNC-11 scale score ≥32. The intervention group will participate in a 4-month group PA program. The program will comprise two walks per week and a monthly visit to a sociocultural facility. RESULTS: Measured outcomes are clinical remission of depression (BDI-II score <14) and anxiety (GAD-7 scale score <10), improved social support (reduction in DUKE-UNC-11 score), improved quality of life and/or response to the intervention at 4 and 12 months post-intervention. Intervention satisfaction and adherence and post-intervention links with sociocultural organizations will also be assessed. CONCLUSION: The findings could encourage the provision of activity-based community interventions for older individuals.