Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis

NCT ID: NCT04138784

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2020-03-31

Brief Summary

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Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks individualized comprehensive rehabilitation program with elastic bands on pain and functional disability in chronic knee osteoarthritis.

Detailed Description

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The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues, and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that an individualized comprehensive rehabilitation program uring 8 weeks would benefit women with knee osteoarthritis.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Comprehensive Rehabilitation program

19 women will be recruited in order to the inclusion criteria for the study and they will receive an 8-weeks individualized comprehensive rehabilitation program administered once a day.

Group Type EXPERIMENTAL

Individualized comprehensive rehabilitation program

Intervention Type OTHER

The program general contents were pain education, joint protection techniques, general care lifestyle habits, which were complemented by a problem-based session. The program plan was designed to fit patients' goals, priorities, and lifestyles after an initial interview.

Aquatic training

18 women will be recruited in order to the inclusion criteria for the study and they will receive an 8-weeks hydrotherapy intervention once a day.

Group Type EXPERIMENTAL

Aquatic training

Intervention Type OTHER

Patients received a 45 min-water exercise program which included balance and proprioception activities, isometric exercise, flexibility exercises, core stabilization exercises and aerobic/endurance exercises. All sessions were developed in groups and addressed by a qualified professional.

Interventions

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Individualized comprehensive rehabilitation program

The program general contents were pain education, joint protection techniques, general care lifestyle habits, which were complemented by a problem-based session. The program plan was designed to fit patients' goals, priorities, and lifestyles after an initial interview.

Intervention Type OTHER

Aquatic training

Patients received a 45 min-water exercise program which included balance and proprioception activities, isometric exercise, flexibility exercises, core stabilization exercises and aerobic/endurance exercises. All sessions were developed in groups and addressed by a qualified professional.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary symptomatic KOA according to the criteria of the American College of Rheumatology
* Women aged older than 65 years
* Pain predominantly over the last 3 months
* Kellgren and Lawrence score ≥2.

Exclusion Criteria

* Ankle, hip or foot severe disorders
* Chronic back pain
* Alzheimer's disease, Parkinson's disease, motor neuron disorders.
* Diabetes mellitus
* Cardiac or respiratory insufficiency
* Inability to understand the procedure
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Marie Carmen Valenza

Assistant profressor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Marie Carmen Valenza, PhD

Role: CONTACT

958242360

References

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Lopez LL, Benitez PO, Lopez JC, Martos IC, Torres JR, Santiago MG, Valenza MC. Effectiveness of an individualized comprehensive rehabilitation program in women with chronic knee osteoarthritis: a randomized controlled trial. Menopause. 2022 Jun 1;29(6):687-692. doi: 10.1097/GME.0000000000001959.

Reference Type DERIVED
PMID: 35674649 (View on PubMed)

Other Identifiers

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DF0083UG

Identifier Type: -

Identifier Source: org_study_id

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