Progressing Home Health Rehabilitation for Older Adults

NCT02905370 | Completed DMC

• 2 other identifiers: 15-2125R01NR016209
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

Brief Summary

This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on functionally enhanced care transitions) with usual care physical therapy.

Conditions

Older Adults; Physical Deconditioning

Keywords

Home Health; Rehabilitation; High Intensity; Hospital Associated Deconditioning; Functional Mobility; Physical Function

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB)

  SPPB is a well-accepted global measure of lower extremity function which consists of walking speed, chair stands, and balance. It is a well-studied composite measure and a strong predictor of disability, institutionalization, and morbidity in older adults. SPPB will also be assessed at 30, 90, 180 days post-randomization.

  Change in SPPB from baseline to 60 days post randomization

Secondary Outcomes (7)

• Modified Physical Performance Test (mPPT)

  Change in mPPT from baseline to 60 days post randomization

• Fast walking speed (4MW)

  Change in 4MW from baseline to 60 days post randomization

• ActivPAL

  Change in physical activity from baseline to 60 days post randomization

• Falls Efficacy Scale-International

  Change in Falls Efficacy Scale-International from baseline to 60 days post randomization

• Fatigue Severity Scale (FSS)

  Change in FSS from baseline to 60 days post randomization

Other Outcomes (1)

• Falls, Emergency Department visits, nursing home days, hospitalizations

  Quantification of falls, ED visits, nursing home days, and hospitalizations at 30, 60, 90, and 180 days post randomization

Study Arms (3)

Progressive Multi-Component (PMC)

EXPERIMENTAL

High intensity strength training protocol, daily protein supplementation, functionally enhanced transitions of care

Behavioral: Progressive Multi-Component (PMC)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Low intensity rehabilitation protocol, standard education for nutrition, standard transitions of care Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group.

Behavioral: Enhanced Usual Care (EUC)

True Usual Care (TUC)

NO INTERVENTION

Real-world home health rehabilitation, real-world education for nutrition, real-world transitions of care, non-randomized observation Participants in the "True Usual Care" group will receive physical therapy following discharge from acute hospitalization. Activities and number of visits are not protocolized and are provided by real world home health care providers per physician orders. Participant Arm added effective 8/16/18.

Interventions

Progressive Multi-Component (PMC) BEHAVIORAL

Participants in the "Progressive Multi-component" intervention group will receive 1) high intensity physical therapy, 2) protein supplement, and 3) emphasis on functionally enhanced transitions of care following discharge from post-acute setting. High intensity physical therapy will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Functionally enhanced transitions of care protocol includes a personal health record with 5 domains that are addressed in an interdisciplinary manner with the patient. Participants will receive 12 intervention visits over 60 days. Participants will also receive a home exercise program.

Progressive Multi-Component (PMC)

Enhanced Usual Care (EUC) BEHAVIORAL

Participants in the "Enhanced Usual Care" group will receive standardized physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 60 days. Participants will also receive a standardized home exercise program and standard nutritional education. Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group.

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age and older
• Referred to home care physical therapy following acute medical deconditioning
• Have at least 3 comorbid conditions including those listed below:
• Chronic Obstructive Pulmonary Disease
• Gastrointestinal Bleed
• Urinary Tract Infection
• Pneumonia
• Chronic ulcerative wounds
• Diabetes
• Hypertension
• Depression/mental health
• Irritable Bowel Syndrome
• Hernia
• Post-op pancreatic surgery
• Osteoporosis/OA/RA/Gout

You may not qualify if:

• Acute lower extremity fracture with weight-bearing restriction
• "Elective" joint replacement surgery
• Lower extremity amputation
• Acute cardiac surgery
• Terminal illness
• Active cancer treatment in which exercise is contraindicated
• Deep vein thrombosis/pulmonary embolus (DVT/PE)
• Recent stroke (within 1 yr)
• Inability to ambulate 10 feet without human assistance at time of hospital discharge
• Gait Speed \<0.3m/s or \>1.0 m/s
• Progressive neurodegenerative diagnosis (e.g. Parkinson's, MS, ALS)
• Use of illegal substances
• Active involvement of Adult Protection Services
• Current dialysis treatment
• Prisoners or those on probation or other alternative sentencing

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Nursing Research (NINR): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Arcadia University: collaborator

Study Sites (1)

University of Colorado Denver, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (6)

• Cawood AL, Elia M, Stratton RJ. Systematic review and meta-analysis of the effects of high protein oral nutritional supplements. Ageing Res Rev. 2012 Apr;11(2):278-96. doi: 10.1016/j.arr.2011.12.008. Epub 2011 Dec 22.

  PMID: 22212388 BACKGROUND

• Fisher SR, Kuo YF, Sharma G, Raji MA, Kumar A, Goodwin JS, Ostir GV, Ottenbacher KJ. Mobility after hospital discharge as a marker for 30-day readmission. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):805-10. doi: 10.1093/gerona/gls252. Epub 2012 Dec 19.

  PMID: 23254776 BACKGROUND

• Murkofsky RL, Alston K. The past, present, and future of skilled home health agency care. Clin Geriatr Med. 2009 Feb;25(1):1-17, v. doi: 10.1016/j.cger.2008.11.006.

  PMID: 19217489 BACKGROUND

• Solomon DH, Wagner DR, Marenberg ME, Acampora D, Cooney LM Jr, Inouye SK. Predictors of formal home health care use in elderly patients after hospitalization. J Am Geriatr Soc. 1993 Sep;41(9):961-6. doi: 10.1111/j.1532-5415.1993.tb06762.x.

  PMID: 8409182 BACKGROUND

• Timmer AJ, Unsworth CA, Taylor NF. Rehabilitation interventions with deconditioned older adults following an acute hospital admission: a systematic review. Clin Rehabil. 2014 Nov;28(11):1078-86. doi: 10.1177/0269215514530998. Epub 2014 May 20.

  PMID: 24844238 BACKGROUND

• Falvey JR, Mangione KK, Nordon-Craft A, Cumbler E, Burrows KL, Forster JE, Stevens-Lapsley JE. Progressive Multicomponent Intervention for Older Adults in Home Health Settings Following Acute Hospitalization: Randomized Clinical Trial Protocol. Phys Ther. 2019 Sep 1;99(9):1141-1149. doi: 10.1093/ptj/pzz069.

  PMID: 31004493 DERIVED

Study Officials

• Jennifer E Stevens-Lapsley, MPT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: September 28, 2016
• Primary Completion: May 6, 2022
• Study Completion: June 3, 2022
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)