search
Back to results

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

Primary Purpose

Mobility Limitation, Sedentary Lifestyle, Older Adults

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group exercise
Sponsored by
Northeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mobility Limitation

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northeastern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group exercise

Attention-Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Seven-day free living physical activity
Number of steps per day were objectively measured with an activity monitor worn for a seven-day period

Secondary Outcome Measures

Full Information

First Posted
April 7, 2017
Last Updated
April 30, 2018
Sponsor
Northeastern University
search

1. Study Identification

Unique Protocol Identification Number
NCT03514160
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Sedentary Lifestyle, Older Adults

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group exercise
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Attention-Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group exercise
Intervention Description
Group exercise based on the American College of Sports Medicine guidelines.
Primary Outcome Measure Information:
Title
Seven-day free living physical activity
Description
Number of steps per day were objectively measured with an activity monitor worn for a seven-day period
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Castaneda-Sceppa, MD, PhD
Organizational Affiliation
Professor and Chair
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northeastern University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs