Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Effectiveness of an Individualized Comprehensive Rehabilitation Program in Disabled Chronic Knee Osteoarthritis Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04138784
• Other study ID #: DF0083UG
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2019
• Est. completion date: March 2020

Study information

• Verified date: November 2019
• Source: Universidad de Granada
• Contact: Marie Carmen Valenza, PhD
• Phone: 958242360
• Email: cvalenza[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: March 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Functionality	Changes in Functionality is going to be assessed by the Western Ontario and McMaster Universities (WOMAC). Scores range from 0 to 96, with higher scores indicating greater disease severity.	Baseline, 8 weeks, 3 months
Primary	Changes in Physical Performance	Changes in Physical Performance is going to be assessed using the Stairs Climbing Test. This test assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.	Baseline, 8 weeks, 3 months
Primary	Changes in Physical Performance	Changes in Physical Performance is going to be assessed by The Timed up ad go. It involves a person standing from a 46-cm-high chair, walking 3 m, turning, walking back to the chair and sitting down.	Baseline, 8 weeks, 3 months
Primary	Changes in Perceived Health Status	Changes in Perceived Health Status is going to be assessed by the EuroQol-5D.It contains two sections, a descriptive section and a valuation section. The descriptive section is a health status classification instrument with the following five dimensions: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. In the second section, respondents are asked to value their overall health status on a visual analogue scale ranging from 0 (defined as the worst imaginable health state) to 100 (defined as the best imaginable health state)	Baseline, 8 weeks, 3 months