NCT02048956

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

January 27, 2014

Last Update Submit

November 1, 2016

Conditions

Keywords

knee osteoarthritishydrotherapy

Outcome Measures

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.

    baseline, 8 weeks

Secondary Outcomes (4)

  • Changes in lower extremity strength

    baseline, 8 weeks

  • Dual task

    baseline, 8 weeks

  • Functional ability

    baseline, 8 weeks

  • Changes in balance

    baseline, 8 weeks

Other Outcomes (1)

  • Quality of sleep

    baseline, 8 weeks

Study Arms (2)

Hydrotherapy intervention

EXPERIMENTAL

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

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.

Other: Control group

Interventions

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
Hydrotherapy intervention

Standard exercises of hydrotherapy

Also known as: Standard hydrotherapy intervention
Control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed clinical diagnosis of knee osteoarthritis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of health Sciences. University of Granada

Granada, Spain, 18071, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Resistance TrainingControl Groups

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 29, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations