NCT03514160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2017

Enrollment Period

4 months

First QC Date

April 7, 2017

Last Update Submit

April 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group exercise

ACTIVE COMPARATOR

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

Attention-Control group

NO INTERVENTION

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.

Interventions

Group exerciseBEHAVIORAL

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

Group exercise

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Mobility LimitationSedentary Behavior

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Carmen Castaneda-Sceppa, MD, PhD

    Professor and Chair

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2017

First Posted

May 2, 2018

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Study Completion

January 1, 2016

Last Updated

May 2, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations