NCT02942992

Brief Summary

To develop an intervention specifically targeted for these clients who have the frailty syndrome. The Investigators propose to develop an exercise intervention that can reduce frailty in older adults to facilitate their ability to age-in-place. The long-term objective of this work is to develop a package of interventions that can be administered within the existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal of this proposal is to develop a resistance exercise intervention to reduce frailty in older adults receiving long term care services in their home through the Illinois Community Care Program, a HCBS Waiver Program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

October 4, 2016

Last Update Submit

March 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with frailty or pre-frailty as assessed by the SHARE-FI

    26 weeks

Secondary Outcomes (2)

  • Scores of self-reported overall health as measured by the PROMIS-global health

    26 weeks

  • Quadriceps muscle strength as assessed by the 30 second chair rise test

    26 weeks

Study Arms (2)

Control

NO INTERVENTION

Usual Care Group

Intervention

OTHER

Intervention Group

Behavioral: Resistance exercise

Interventions

resistance exercise

Intervention

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \- Employees of Help at Home, with one eligible client
  • aged 65+ years
  • receive HCA services two or more days per week
  • English-speaking
  • not currently participating in regular exercise as defined as 30 minutes three or more days per week, - - no health problems that contraindicate participation in exercise based on the EASY: Exercise Assessment and Screening for You
  • Telephone Interview for Cognitive Status score \> 26

You may not qualify if:

  • \- no clients who enroll in the study
  • legally blind, no voluntary extremity movement
  • physician does not provide clearance for participation
  • classified as non-frail based on the SHARE-FI frailty testing
  • Telephone Cognitive Status score \< 25.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Danilovich MK, Diaz L, Ciolinio JD, Corcos DM. Functional resistance activities to impact frailty: A protocol for a randomized controlled trial involving home care aide and frail older adult dyads. Contemp Clin Trials Commun. 2017 May 12;7:28-32. doi: 10.1016/j.conctc.2017.05.006. eCollection 2017 Sep.

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 24, 2016

Study Start

March 30, 2017

Primary Completion

August 8, 2017

Study Completion

July 31, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations