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CompletedNCT02048956Updated Nov 2, 2016

Hydrotherapy Intervention in Elderly With Knee Osteoarthritis

An interventional study of Hydrotherapy intervention and Control group in Knee Osteoarthritis, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • knee osteoarthritis
  • hydrotherapy
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 34 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 244 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed clinical diagnosis of knee osteoarthritis

Exclusion criteria

Exclusion Criteria:

  • total knee arthroplasty
  • inability to co-operate or follow instructions.
  • a major neurological disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Hydrotherapy intervention

    30 people will be recruited in order to the inclusion criteria for the study and they will receive an hydrotherapy intervention.

    Other: Hydrotherapy intervention

  • Active comparator
    Control group

    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.

    Other: Control group

Interventions

  • OtherHydrotherapy intervention

    Participants randomized to the exercise programme received a training in a swimming pool focused on dance therapy.

    Also known as: Exercise program, Swimming pool training

  • OtherControl group

    Standard exercises of hydrotherapy

    Also known as: Standard hydrotherapy intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 8 weeks

Secondary outcomes

  1. 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.

    Time frame: baseline, 8 weeks

  2. 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.

    Time frame: baseline, 8 weeks

  3. 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.

    Time frame: baseline, 8 weeks

  4. 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

    Time frame: baseline, 8 weeks

Other outcomes

  1. Quality of sleep

    Quality of sleep was assessed by Pittsburgh Sleep Quality Index, a self-reported questionnaire.

    Time frame: baseline, 8 weeks

07

Study locations

1 site
  • Faculty of health Sciences. University of Granada
    Granada, Spain 18071, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of May 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2014
First posted
Jan 29, 2014
Start
Jan 2014
Primary completionActual
May 2016
CompletionActual
Aug 2016
Last update
Nov 2, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02048956
Responsible party
Marie Carmen Valenza (assistant professor, Universidad de Granada) — Principal investigator
First posted
Jan 29, 2014
Start date
Jan 2014
Primary completion
May 2016
Completion
Aug 2016
Last update
Nov 2, 2016

Study contacts

Marie Carmen Valenza, PhD
principal investigator · Universidad de Granada

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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