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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02433249
Other study ID # 1402S47802
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2014
Est. completion date June 2015

Study information

Verified date October 2019
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this pilot study is to develop an intervention, based on empirical evidence and health-related behavioral change theory, to enhance motivation for engaging in fall-reducing physical activities.


Description:

The intervention being developed, Ready~Steady, combines 3 components; a) interpersonal motivation, b) intrapersonal motivation, and c) physical activity. Theoretical concepts from the wellness motivation theory are (a) translated into intervention strategies; and (b) operationalized as variables to form a basis for evaluating this intervention. The overall objective is to advance the development of Ready~Steady by assessing the impact of its motivation components.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- = 70 years, level of physical activity (strength training and aerobic) below national recommendations

Exclusion Criteria:

- Dementia, recent injury or surgery, unable to participate in light-moderately intense exercise

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
1 Physical Activity
Fall reducing strength (5), balance (12) and flexibility (4) exercises as well as walking. Participants were also given a Fitbit One with instructions on how to use
Interpersonal Motivation
Strategies used to support Interpersonal motivational targets include: a) discuss and model ways to provide and receive more support for physical activity, b) identify environmental barriers to being physically active, c) problem-solve environmental and social barriers to being physically active, d) use and create new resources that support physical activity behavior
Intrapersonal Motivation
Strategies used to support intrapersonal motivation included a) use of the goal attainment scale, b) facilitating the formation of action plans, c) identify and problem solve personal barriers to being active, d) identify satisfying aspects of being active, e) self-evaluate physical activity patterns and progress.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

References & Publications (4)

McMahon S, Fleury J. Wellness in older adults: a concept analysis. Nurs Forum. 2012 Jan-Mar;47(1):39-51. doi: 10.1111/j.1744-6198.2011.00254.x. — View Citation

McMahon S, Talley KM, Wyman JF. Older people's perspectives on fall risk and fall prevention programs: a literature review. Int J Older People Nurs. 2011 Dec;6(4):289-98. doi: 10.1111/j.1748-3743.2011.00299.x. Review. — View Citation

McMahon S, Vankipuram M, Hekler EB, Fleury J. Design and evaluation of theory-informed technology to augment a wellness motivation intervention. Transl Behav Med. 2014 Mar;4(1):95-107. doi: 10.1007/s13142-013-0221-4. — View Citation

Perez A, Fleury J. Wellness motivation theory in practice. Geriatr Nurs. 2009 Mar-Apr;30(2 Suppl):15-20. doi: 10.1016/j.gerinurse.2009.02.006. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Technology acceptability and utility 10 item survey addressing wearable technology's learnability, utility and role in supporting individual motivation 1 week post; 6 months post
Primary Change in self-reported physical activity behavior Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire Baseline; 1 week post; 6 months post
Primary Change in objectively measured physical activity behavior Accelerometers built in to Fitbit Ones Baseline; 1 week post; 6 months post
Secondary Change in functional strength and balance Short Physical Performance Battery Baseline; 1 week post; 6 months post
Secondary Change in functional strength and balance Timed Up and Go Baseline; 1 week post; 6 months post
Secondary Change in the number of community resources used for physical activity Number of community resources identified and used: 2 item survey Baseline; 1 week post; 6 months post
Secondary Change in social support for fall-reducing physical activities Social support for exercise: Survey Baseline; 1 week post; 6 months post
Secondary Change in readiness Index of Readiness Baseline; 1 week post; 6 months post
Secondary Change in self-regulation Index of Self-Regulation Baseline; 1 week post; 6 months post
Secondary Change in self-reported lower extremity function Neuro-QOL SF v1.0 - LEx Fnct (Mobility) Baseline; 1 week post; 6 months post
Secondary Change in self-reported ability to participate in social activities PROMIS SF v2.0 - Ability to Participate Social 4a Baseline; 1 week post; 6 months post
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