NCT02696382

Brief Summary

The investigators plan to test an innovative, home-based, short duration, high intensity exercise program designed for application in the immediate post-hospitalization period in older Veterans. Preliminary data suggest a more intensive approach to physical therapy in older adults after hospitalization is safe and maximizes mobility more than usual care. The Veterans participating in the high intensity exercise program will receive therapy utilizing higher resistance exercises. Outcomes from this group will be compared to data collected from the patients receiving standard, lower resistance therapies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

September 1, 2023

Enrollment Period

5.2 years

First QC Date

February 19, 2016

Results QC Date

September 2, 2022

Last Update Submit

September 27, 2023

Conditions

Frail ElderlyHomebound Persons

Keywords

VeteransProgressive High Intensity Physical TherapyGait SpeedAcute HospitalizationHospital Associated Deconditioning

Outcome Measures

Primary Outcomes (1)

  • Change in Self-Selected Walking Speed

    Will be assessed at the subject's self selected speed for each participant over 4 meters. Faster walking indicates capacity for performance of certain activities (e.g. crossing a street before the light changes).

    From baseline to 60 days post-baseline

Secondary Outcomes (34)

  • Short Physical Performance Battery (SPPB)

    Baseline

  • Short Physical Performance Battery (SPPB)

    30 Days

  • Short Physical Performance Battery (SPPB)

    60 Days

  • Short Physical Performance Battery (SPPB)

    90 Days

  • Short Physical Performance Battery (SPPB)

    180 Days

  • +29 more secondary outcomes

Other Outcomes (18)

  • Patient Activation Measure Survey (PAM)

    Baseline

  • Step Count

    Baseline

  • Step Count

    60 Days

  • +15 more other outcomes

Study Arms (2)

Usual Care (UC)

ACTIVE COMPARATOR

Participants in the "Usual Care" (UC) group will receive standard, low-intensity physical therapy following discharge from acute hospitalization.

Behavioral: Usual Care (UC)

Progressive High Intensity Therapy

EXPERIMENTAL

Participants in the "Progressive High Intensity Therapy" (PHIT) group will receive high intensity physical therapy following discharge from acute hospitalization.

Behavioral: Progressive High Intensity Therapy (PHIT)

Interventions

Progressive High Intensity Therapy (PHIT)BEHAVIORAL

Participants in the "Progressive High Intensity Therapy" (PHIT) group will receive high intensity physical therapy following discharge from acute hospitalization. The activities of training will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Like the Usual Care group, the PHIT participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.

Progressive High Intensity Therapy
Usual Care (UC)BEHAVIORAL

Participants in the "Usual Care" group will receive standard 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 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.

Usual Care (UC)

Eligibility Criteria

Age55 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recent hospitalization or period of deconditioning
  • Veteran Status
  • Referred to or eligible for home health physical therapy
  • Have at least 3 comorbid conditions including: Chronic Obstructive Pulmonary Disease (COPD), pneumonia, hypertension, hernia, heart disease, spinal stenosis, atrial fibrillation, post-op bowel surgery, gastrointestinal bleed, chronic ulcerative wounds, depression/ mental health, post-op pancreatic surgery, hypercholesterolemia, dehydration, hypo/hyperthyroid, congestive heart failure, urinary tract infection, diabetes, irritable bowel syndrome, osteoporosis, osteoarthritis, rheumatoid arthritis, gout, peripheral artery disease, syncope, renal failure-no dialysis
  • Be ambulatory without human assistance prior to hospitalization

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
  • Cancer
  • Alzheimer's disease
  • Deep vein thrombosis
  • Recent stroke
  • Degenerative neurological conditions
  • Gait speed slower than 0.3 m/s or \>1.0 meters/second
  • Inability to walk 10 feet without human assistance --History of illegal substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

Related Publications (5)

  • Mangione KK, Lopopolo RB, Neff NP, Craik RL, Palombaro KM. Interventions used by physical therapists in home care for people after hip fracture. Phys Ther. 2008 Feb;88(2):199-210. doi: 10.2522/ptj.20070023. Epub 2007 Dec 4.

    PMID: 18056752BACKGROUND

  • Falvey JR, Mangione KK, Stevens-Lapsley JE. Rethinking Hospital-Associated Deconditioning: Proposed Paradigm Shift. Phys Ther. 2015 Sep;95(9):1307-15. doi: 10.2522/ptj.20140511. Epub 2015 Apr 23.

    PMID: 25908526BACKGROUND

  • Tinetti ME, Baker D, Gallo WT, Nanda A, Charpentier P, O'Leary J. Evaluation of restorative care vs usual care for older adults receiving an acute episode of home care. JAMA. 2002 Apr 24;287(16):2098-105. doi: 10.1001/jama.287.16.2098.

    PMID: 11966384BACKGROUND

  • Andersen LL, Andersen CH, Mortensen OS, Poulsen OM, Bjornlund IB, Zebis MK. Muscle activation and perceived loading during rehabilitation exercises: comparison of dumbbells and elastic resistance. Phys Ther. 2010 Apr;90(4):538-49. doi: 10.2522/ptj.20090167. Epub 2010 Feb 4.

    PMID: 20133444BACKGROUND

  • El Solh A, Pineda L, Bouquin P, Mankowski C. Determinants of short and long term functional recovery after hospitalization for community-acquired pneumonia in the elderly: role of inflammatory markers. BMC Geriatr. 2006 Aug 9;6:12. doi: 10.1186/1471-2318-6-12.

    PMID: 16899118BACKGROUND

Results Point of Contact

Title
Dr. Jennifer Stevens-Lapsley
Organization
University of Colorado Denver
jennifer.stevens-lapsley@cuanschutz.edu
303.724.9170

Study Officials

  • Jennifer E. Stevens-Lapsley, PhD

    Rocky Mountain Regional VA Medical Center, Aurora, CO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2016

First Posted

March 2, 2016

Study Start

April 1, 2016

Primary Completion

May 31, 2021

Study Completion

October 8, 2021

Last Updated

April 1, 2024

Results First Posted

April 1, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)