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Relationships Between Exercise and Emotion Regulation on Physical Activity in Frail Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514160
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Northeastern University

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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Sedentary Lifestyle Older Adults Behavioral: Group exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does Exercise-induced Improvements in Emotion Regulation Enhance Daily Physical Activity and Well-being in Frail Sedentary Older Adults?
Actual Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group exercise
Group exercise training at a community site. Exercises included supervised upper and lower-body strength and balance exercises twice per week. Hand-made, weighted bars were used for resistance props and balance. The exercises included: chair squats; standing single leg hip abduction; hip extension; balance heal-to-toe walking; seated hip adduction and knee extension; wall push-ups; bent-over rows; shoulder press; elbow flexion and extension).
Behavioral: Group exercise
Group exercise based on the American College of Sports Medicine guidelines.

No Intervention: Attention-Control group
Attendance to community site usual activities offered to older adults. Participants in this group were offered the exercise routine after completing the 12-week study.



Primary Outcome Measures :
  1. Seven-day free living physical activity [ Time Frame: 12 weeks ]
    Number of steps per day were objectively measured with an activity monitor worn for a seven-day period



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514160


Locations
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United States, Massachusetts
Northeastern University
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Northeastern University
Investigators
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Principal Investigator: Carmen Castaneda-Sceppa, MD, PhD Professor and Chair
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Responsible Party: Northeastern University
ClinicalTrials.gov Identifier: NCT03514160    
Other Study ID Numbers: G00004606
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mobility Limitation