Clinical trial NCT03514160: Relationships Between Exercise and Emotion Regulation on Physical Activity in Frail Older Adults
Official title: Does Exercise-induced Improvements in Emotion Regulation Enhance Daily Physical Activity and Well-being in Frail Sedentary Older Adults?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Sedentary Lifestyle
Older Adults
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to group exercise or an attention-control group for 12 weeks (2:1 ratio). Group exercise sessions took place once per week at a community center.
Primary purpose: OTHER

Brief summary: Frailty in older adults is a consequence of physical inactivity, which leads to poor physical function, disability and poor health outcomes. Nearly 60% of older adults report inactivity. Emotion regulation strategies have affective, cognitive and social consequences. Positive emotions are significantly associated with a higher ability to perform activities of daily living. There is a gap in the understanding of how exercise influences the selection of emotion regulation strategies (avoidant vs. adaptive) in frail older adults. The investigators propose to examine the interactions between regular exercise, selection of emotional regulation strategies, and daily physical activity in frail sedentary older adults.

Detailed description: 1. Determine the choice of emotion regulation strategies used by frail sedentary older adults (60+ years; n=24). Frailty will be defined as a gait speed \<0.8 m/sec.

   Hypothesis: Frail sedentary older adults will choose avoidant emotion regulation strategies.
2. Examine whether a peer-led, community-based, group-exercise program lasting 12-weeks improves the selection of emotion regulation strategies in frail sedentary older adults as compared to those receiving support services (12/group).

   Hypothesis: Exercise will result in higher use of adaptive emotion regulation strategies than support services.
3. Examine if improved selection of emotional regulation strategies with exercise translates into increased daily physical activity and reduced sedentary behavior by frail older adults as compared to those receiving support services.

   Hypothesis: Exercise will significantly increase daily physical activity and decrease sedentary behavior than support services.
4. Determine if improvements in emotional regulation strategy selection and daily physical activity levels positively influence health and well-being (i.e. health status, physical function, mood, depressive symptoms, anxiety, and sense of loneliness and isolation).

Hypothesis: Exercise-induced improvements in emotion regulation and increased daily physical activity will be associated with improved overall health and well-being as compared to support services.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling older adults 60+ years of age
* Men and women
* Frail older adults with impaired mobility (gait speed \< 0.8 m/sec)
* Sedentary older adults

Exclusion Criteria:

* Unable to give consent
* Unable to exercise
* Unable to travel to the community site
* Unstable chronic conditions

Primary outcomes:
measure: Seven-day free living physical activity
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
affiliation: Professor and Chair
name: Carmen Castaneda-Sceppa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: