Exercises in the Post-operative Rehabilitation of THA

NCT03208829 | Unknown

• 1 other identifier: THA Rehabilitation
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One group will receive a booklet with guidelines for postoperative care, while the other group will participate in face-to-face sessions with exercises with emphasis on muscle strengthening.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 6 Weeks Post-Intervention Muscle Strength

  Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).

  Will be measured post intervention 6 weeks after intervention).

Secondary Outcomes (6)

• Functional Capacity (TUG)

  Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).

• Functional Capacity (HHS)

  Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).

• Hip Range of Motion

  Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).

• Pain in the operated hip (last seven days)

  Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).

• 1 Week Post-Intervention Muscle Strength

  Will be measured post intervention (1 week after intervention).

Other Outcomes (4)

• Body Mass Index

  Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).

• Length of Lower Limbs

  Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).

• Kinesiophobia

  Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).

Study Arms (2)

Group 1

EXPERIMENTAL

Rehabilitation Exercises Group 1 will be submitted to an exercise protocol based on muscle strength training, with duration of 6 weeks and frequency of two weekly sessions, lasting 45 minutes.

Other: Rehabilitation exercises

Group 2

ACTIVE COMPARATOR

Postoperative guidance Group 2 will receive an orientation booklet and weekly links from researchers to address possible questions.

Other: Postoperative guidance

Interventions

Rehabilitation exercises OTHER

Patients in group 1 will participate in a physical exercise protocol supervised by a physiotherapist. The sessions will focus on the rehabilitation of muscle strength and the exercises will be performed with increased external load.

Group 1

Postoperative guidance OTHER

Group 2 will receive only guidelines regarding postoperative care.

Group 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred by orthopedic doctors of the city of Porto Alegre, Rio Grande do Sul, Brazil;
• Between 30-60 days of unilateral total hip arthroplasty (cemented and hybrid prostheses) postoperative phase;
• Read and consent to the Free and Informed Consent Form and understood the guidelines necessary to carry out the evaluations proposed in this research.

You may not qualify if:

• Performing a surgical procedure, in the last six months, in other articular joints in the lower limbs;
• previous surgical procedures in the coxofemoral joint;
• surgical procedures and osteoarticular diseases in the lumbar spine;
• osteoarticular diseases in lower limb joints;
• muscle injuries in lower limbs;
• presence of signs or symptoms of osteoarthritis in the contralateral hip;
• postoperative complications such as prosthesis dislocation, deep venous thrombosis, periarticular fractures and neural lesions;
• intra-articular injection of corticosteroids in the lower limbs during the last six months;
• cardiovascular diseases with presence of disability, such as severe dyspnea and uncontrolled arterial hypertension;
• presence of neurological diseases.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Federal Health Science University of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Bruna M Lopes, PhD Student

  Federal Health Science University of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruna M Lopes, PhD Student

CONTACT

+5551993276096; blopes.fisio@gmail.com

Marcelo F Silva, PhD

CONTACT

marcelofs@ufcspa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The random allocation step will be conducted through Randomizers - www.random.org by a research assistant. The assistant responsible for randomization will not be involved in any other phase of the study and the secrecy of the allocation will be maintained through opaque envelopes. A second independent assistant will administer the agenda and all communication between the participants and the researchers involved
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PhD student)

Model Details: Patients with total hip arthroplasty, will be assigned to two different treatment groups.

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: July 6, 2017
• Study Start: May 4, 2018
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)