NCT02780037

Brief Summary

This study examines the short- and long-term-effects of different repeated frames in which an exercise program is offered on behavior (i.e., frequency of exercise) and motivation (i.e., autonomous/controlled) in older people (65+). The frames are manipulated experimentally as either prevention focused (e.g., to prevent worse health), promotion focused (e.g., to gain better health) or neutral (control condition).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 6, 2017

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

February 23, 2016

Last Update Submit

November 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Behavior at long term: exercise frequency during third week

    self-reported no exercise sessions

    third week

Secondary Outcomes (5)

  • Change in controlled motivation over long term: end week 3 - baseline

    3 weeks

  • Change in autonomous motivation over long term: end week 3 - baseline

    3 weeks

  • Change in controlled motivation over short term: end week 1 - baseline

    1 week

  • Change in autonomous motivation over short term: end week 1 - baseline

    1 week

  • Behavior at short term: exercise frequency during first week

    first week

Other Outcomes (11)

  • Functionality: sit to stand/sit: flexion, extension, stand and sit duration (time)

    week 1/week 2/week 3

  • Functionality: sit to stand/sit: angular velocity flexion and extension (degrees/sec)

    week 1/week 2/week 3

  • Functionality: sit to stand/sit: range flexion and extension (degrees)

    week 1/week 2/week 3

  • +8 more other outcomes

Study Arms (3)

Prevention

EXPERIMENTAL

Regulatory frame: prevention

Behavioral: Regulatory frame: prevention

Promotion

EXPERIMENTAL

Regulatory frame: promotion

Behavioral: Regulatory frame: promotion

Neutral

SHAM COMPARATOR

Regulatory frame: not implied

Behavioral: Regulatory frame: not implied

Interventions

Exercise program presented as preventing deterioration.

Prevention

Exercise program presented as promoting improvement.

Promotion

Exercise program presented without implied consequences.

Neutral

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age

You may not qualify if:

  • severe mental/physical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology

Heverlee, Vlaams-Brabant, 3001, Belgium

Location

Related Publications (1)

  • Vanroy J, Seghers J, van Uffelen J, Boen F. Can a framed intervention motivate older adults in assisted living facilities to exercise? BMC Geriatr. 2019 Feb 18;19(1):46. doi: 10.1186/s12877-019-1060-z.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

May 23, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 6, 2017

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations