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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03514160
Other study ID # G00004606
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date January 2016

Study information

Verified date April 2017
Source Northeastern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2016
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 60 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group exercise
Group exercise based on the American College of Sports Medicine guidelines.

Locations

Country Name City State
United States Northeastern University Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seven-day free living physical activity Number of steps per day were objectively measured with an activity monitor worn for a seven-day period 12 weeks
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