Knee OsteoarthritisNCT02048956
Hydrotherapy Intervention in Elderly With Knee Osteoarthritis
A study testing Hydrotherapy intervention in people with Knee Osteoarthritis, run by Universidad de Granada at 1 site in Spain.
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 hydrotherapy training with elastic bands on pain and functional disability in old… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hydrotherapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Aug 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed clinical diagnosis of knee osteoarthritis
Who cannot join
- total knee arthroplasty
- inability to co-operate or follow instructions.
- a major neurological disorder
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of health Sciences. University of Granada
Granada, Spain, 18071
About this study
Official title: 8-weeks Hydrotherapy Intervention in Patients With Knee Osteoarthritis.
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 hydrotherapy training with elastic bands on pain and functional disability in old people with 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 a hydrotherapy treatment during 8 weeks would benefit patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hydrotherapy intervention, Control group
- Keywords
- knee osteoarthritis, hydrotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrotherapy interventionOther
Also called Exercise program, Swimming pool training
Participants randomized to the exercise programme received a training in a swimming pool focused on dance therapy.
Control groupOther
Also called Standard hydrotherapy intervention
Standard exercises of hydrotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hydrotherapy intervention | Experimental | 30 people will be recruited in order to the inclusion criteria for the study and they will receive an hydrotherapy intervention. Receives: Other: Hydrotherapy intervention |
| Control group | Active comparator | 30 people will be recruited and included in this control group. The are not going to receive hydrotherapy treatment, only the treatment they receive as usual. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain pressure threshold
The pain pressure threshold is defined as the minimum amount of pressure necessary to induce pain or tenderness . It was measured using a pressure algometer (Somedic AB, Sweden), which is a device with a 1 cm diameter rubber disc at the end on quadriceps muscle.
Measured: baseline, 8 weeks
Secondary outcomes (4)
Changes in lower extremity strength
Changes in the strength of lower limbs 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
Dual task
Dual task is going to be measured using the Timed Up \& Go. It assesses basic mobility skill as well as strength, balance, and agility.
Measured: baseline, 8 weeks
Functional ability
Functional ability was assessed by the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores on the this questionnaire represent greater limitations in function.
Measured: baseline, 8 weeks
Changes in balance
The in balance after the treatment is going to be assessed using the single leg stance. This is a clinical tool that is often used to assess balance and postural steadiness. Subjects are asked to lift one leg off the floor based on their preference and keep the leg raised as long as possible without touching the other leg or the floor
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048956
- Sponsor's protocol ID
- DF0049UG
- Status last verified
- Nov 2016
- First submitted
- 27 Jan 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 8-weeks Hydrotherapy Intervention in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT02048956
- Acronym / sponsor ID
- DF0049UG
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, hydrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Jan 2014 (estimated)
- 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 hydrotherapy training with elastic bands on pain and functional disability in old people with 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 a hydrotherapy treatment during 8 weeks would benefit patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrotherapy intervention | Experimental | Other: Hydrotherapy intervention30 people will be recruited in order to the inclusion criteria for the study and they will receive an hydrotherapy intervention. |
| Control group | Active comparator | Other: Control group30 people will be recruited and included in this control group. The are not going to receive hydrotherapy treatment, only the treatment they receive as usual. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- confirmed clinical diagnosis of knee osteoarthritis
Key exclusion criteria (3 listed)
- total knee arthroplasty
- inability to co-operate or follow instructions.
- a major neurological disorder
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 |
|---|---|---|
| Hydrotherapy interventionAlso: Exercise program, Swimming pool trainingParticipants randomized to the exercise programme received a training in a swimming pool focused on dance therapy. | Other | Hydrotherapy intervention |
| Control groupAlso: Standard hydrotherapy interventionStandard exercises of hydrotherapy | Other | Control group |
Primary outcome
Changes in pain pressure threshold
Time frame: baseline, 8 weeks
The pain pressure threshold is defined as the minimum amount of pressure necessary to induce pain or tenderness . It was measured using a pressure algometer (Somedic AB, Sweden), which is a device with a 1 cm diameter rubber disc at the end on quadriceps muscle.
4 secondary outcomes
Changes in lower extremity strength
Time frame: baseline, 8 weeks
Dual task
Time frame: baseline, 8 weeks
Functional ability
Time frame: baseline, 8 weeks
Changes in balance
Time frame: baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Knee Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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.
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrotherapy intervention in people with Knee Osteoarthritis, run by Universidad de Granada at 1 site in Spain.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain pressure threshold (time frame: baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.