- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514160
Relationships Between Exercise and Emotion Regulation on Physical Activity in Frail Older Adults
Does Exercise-induced Improvements in Emotion Regulation Enhance Daily Physical Activity and Well-being in Frail Sedentary Older Adults?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Northeastern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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).
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Group exercise based on the American College of Sports Medicine guidelines.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Seven-day free living physical activity
Time Frame: 12 weeks
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Number of steps per day were objectively measured with an activity monitor worn for a seven-day period
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carmen Castaneda-Sceppa, MD, PhD, Professor and Chair
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G00004606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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