Knee OsteoarthritisNCT04138784
Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis
A study testing Individualized comprehensive rehabilitation program and Aquatic training in people with Knee Osteoarthritis, run by Universidad de Granada.
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… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Individualized comprehensive rehabilitation program and Aquatic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of an Individualized Comprehensive Rehabilitation Program in Disabled Chronic Knee Osteoarthritis Women
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.
Read the detailed 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Individualized comprehensive rehabilitation program, Aquatic training
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized comprehensive rehabilitation programOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Rehabilitation program | Experimental | 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. Receives: Other: Individualized comprehensive rehabilitation program |
| Aquatic training | Experimental | 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. Receives: Other: Aquatic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks, 3 months
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.
Measured: Baseline, 8 weeks, 3 months
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.
Measured: Baseline, 8 weeks, 3 months
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)
Measured: Baseline, 8 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study startDec 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138784
- Sponsor's protocol ID
- DF0083UG
- Status last verified
- Nov 2019
- First submitted
- 23 Oct 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35674649
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Individualized Comprehensive Rehabilitation Program in Disabled Chronic Knee Osteoarthritis Women
- ClinicalTrials.gov ID
- NCT04138784
- Acronym / sponsor ID
- DF0083UG
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Rehabilitation program | Experimental | Other: Individualized comprehensive rehabilitation program19 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. |
| Aquatic training | Experimental | Other: Aquatic training18 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Ankle, hip or foot severe disorders
- Chronic back pain
- Alzheimer's disease, Parkinson's disease, motor neuron disorders.
- Diabetes mellitus
- Cardiac or respiratory insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized comprehensive rehabilitation programThe 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. | Other | Comprehensive Rehabilitation program |
| Aquatic trainingPatients 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. | Other | Aquatic training |
Primary outcome
Changes in Functionality
Time frame: Baseline, 8 weeks, 3 months
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.
Changes in Physical Performance
Time frame: Baseline, 8 weeks, 3 months
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.
Changes in Physical Performance
Time frame: Baseline, 8 weeks, 3 months
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.
Changes in Perceived Health Status
Time frame: Baseline, 8 weeks, 3 months
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Derived from this study: PubMed 35674649Lopez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized comprehensive rehabilitation program and Aquatic training in people with Knee Osteoarthritis, run by Universidad de Granada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza, PhD (958242360, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Functionality (time frame: Baseline, 8 weeks, 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04138784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.