NCT02762305

Brief Summary

The hypothesis of this study is that participation in the Retired and Senior Volunteer Program (RSVP) Bone Builders program 1 hour, twice per week, for 12 weeks may result in significant positive changes to the health status of older adult participants as demonstrated by increased leg strength and walking speed, improved balance and balance confidence, and enhanced life satisfaction. These improvements may lead to a reduction in risk of falls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

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, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

May 3, 2016

Last Update Submit

September 21, 2018

Conditions

Keywords

fall riskRSVP bone buildersgroup exerciseolder adultsbalance confidencelife satisfactionbalancewalking speed

Outcome Measures

Primary Outcomes (7)

  • 10 Meter Walking Test

    Measures gait speed

    12 weeks

  • Timed Up and Go Test

    Measures gait speed \& fall risk

    12 weeks

  • Five Time Sit to Stand Test

    Measures leg strength \& fall risk

    12 weeks

  • Computerized Dynamic Posturography with NeuroCom Smart Equitest

    Measures balance abilities \& fall risk

    12 weeks

  • Berg Balance Scale

    Measures balance abilities \& fall risk

    12 weeks

  • Activities-specific Balance Confidence (ABC) Scale

    Measures balance confidence \& fall risk

    12 weeks

  • Satisfaction with Life Scale

    Measures life satisfaction

    12 weeks

Study Arms (1)

RSVP Bone Builder group exercise

EXPERIMENTAL

A group of older adults who are participating in the RSVP Bone Builder group exercise.

Other: RSVP Bone Builders Group Exercise

Interventions

RSVP Bone Builder group exercise

Eligibility Criteria

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

You may qualify if:

  • able to walk independently with or without a cane or walker,
  • not currently participating in the RSVP Bone Builders program,
  • scoring at least 24/30 on the Mini-Mental State Examination (MMSE) and clearance of Physical Activity Readiness Questionnaire (Par-Q)

You may not qualify if:

  • if they use a wheelchair in the community for mobility,
  • have any known neurological, musculoskeletal, cardiopulmonary, or other medical condition that will not allow full participation in the RSVP Bone Builders program, and
  • if the subjects score less than 24/30 on the MMSE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Equilibrium Balance Performance Center

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

Motor ActivityPersonal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jillian Giannini

    California State University, Northridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 4, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations