NCT02933632

Brief Summary

Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

April 13, 2015

Last Update Submit

October 2, 2020

Conditions

Keywords

OsteoarthritisPhysiotherapyRehabilitationClinical TrialsAccelerated rehabilitationHip Replacement Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Merle D'Aubigné and Postel score

    From the moment of hospitalization until the day of hospital discharge, assessed up to four days.

Secondary Outcomes (4)

  • Length of hospital stay

    From the moment of hospitalization until the day of hospital discharge, assessed up to four days.

  • Muscle strength force

    From the moment of hospitalization until the day of hospital discharge, assessed up to four days.

  • Goniometry

    From the moment of hospitalization until the day of hospital discharge, assessed up to four days.

  • Time to beginning the gait.

    From the date of hospitalization until the day that began gait, assessed up to four days.

Study Arms (2)

Standard Assistance Protocol-SAP

ACTIVE COMPARATOR

Patients underwent physical therapy once a day. Patients receive intervention by Physical Therapy-SAP.

Other: Physical Therapy-SAP

Accelerated Rehabilitation Protocol-ARP

ACTIVE COMPARATOR

Patients underwent physical therapy three times a day. Patients receive intervention by Physical Therapy-ARP.

Other: Physical Therapy-ARP

Interventions

* Day 1) Patients started approach after discharged anesthesia. Patients received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise; * Day 2) Patients repeated the exercises learned from day 1. Following the proposed activities patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this second day only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to the next day; * Day 3) Patients repeated the day 2. And the patient who had not started gait training in the day 2, began it on the day 3; * Day 4 and other days) Patients repeated the gait training until the discharge date.

Standard Assistance Protocol-SAP

* Day 1-1°approach) Patients started after discharged anesthesia. Received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise; * Day 1-2°approach) Patients repeated the exercises learned from day 1-1°approach. Following patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this Day 1-2°approach only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to next approach; * Day 1-3°approach) Patients repeat the day 1-2°approach. And the patient, who had not started gait training in the day 1 - second approach, began it in this third approach; * Day 2) Patients repeated three times the day 1-3°approach; * Day 3) Patients repeated three times the day 1-3°approach.

Accelerated Rehabilitation Protocol-ARP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of the Public Health System of our Country that were admitted with hip osteoarthritis diagnose and submitted to a total hip arthroplasty surgery in the Hospital de Clínicas de Porto Alegre (HCPA).

You may not qualify if:

  • Patients who refused to participate in this study;
  • Patients lived in another city;
  • Patients undergoing surgery for total hip arthroplasty due to hip fracture;
  • Patients with cognitive disorders or diseases that adversely affect its cognitive function (Alzheimer's disease, senile dementia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 55, Brazil

Location

Federal University Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90040-060, Brazil

Location

Related Publications (1)

  • Marchisio AE, Ribeiro TA, Umpierres CSA, GalvAo L, Rosito R, Macedo CAS, Galia CR. Accelerated rehabilitation versus conventional rehabilitation in total hip arthroplasty (ARTHA): a randomized double blinded clinical trial. Rev Col Bras Cir. 2020;47:e20202548. doi: 10.1590/0100-6991e-20202548. Epub 2020 Aug 12. English, Portuguese.

Related Links

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Carlos R Galia, Doctor

    Federal University Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Degree

Study Record Dates

First Submitted

April 13, 2015

First Posted

October 14, 2016

Study Start

August 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations