NCT01253798

Brief Summary

The purpose of this study is to determine which group exercise one should choose when hip osteoarthritis patients have undergone hip replacement surgery. To determine this, we want to answer the following research question: Are there differences in function and muscle strength in osteoarthritis patients who conduct group training either on land or in water in the rehabilitation phase following hip replacement surgery?

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

December 2, 2010

Last Update Submit

September 19, 2012

Conditions

Keywords

exercisehydrotherapy

Outcome Measures

Primary Outcomes (3)

  • Function1

    Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).

    Pre-operative

  • Function2

    Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).

    Post-operative

  • Funtion3

    Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).

    After 12 weeks training

Secondary Outcomes (3)

  • Muscle strength1

    Pre-operative

  • Muscle strength2

    Post-operative

  • Muscle strength3

    After 12 weeks training

Study Arms (2)

Group training on land

ACTIVE COMPARATOR

Group training in water and on land are carried out by the same principles, which is to improve general function, and to improve function and strength around the operated hip.

Other: Group training

Group training in water

ACTIVE COMPARATOR

Group training in water and on land are carried out by the same principles, which is to improve general function, and to improve function and strength around the operated hip

Other: Group training

Interventions

Each session lasts 50 minutes and consists of warm-up, mobility training, strength training, balance training and endurance training. Mobility training is conducted to increase range of motion in the operated hip, strength exercises are conducted to strengthen muscles around the operated hip, balance training are conducted to improve stability around the operated hip and endurance training are conducted to increase patients' physical capacity. This is in line with current guidelines for the exercise of osteoarthritis patients.

Group training in waterGroup training on land

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hip osteoarthritis patients who undergo surgery with total prosthesis at St. Olav's Hospital, Department Orkdal.
  • Participants must live in commuting distance from the hospital, as the training is organized as outpatient training
  • Participants must be able to take instruction and master the Norwegian language

You may not qualify if:

  • Patients who experience serious complications after surgery
  • if a person has a disease that causes that one can not complete the planned training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital, department Orkdal

Orkanger, Sør-Trøndelag, 7030, Norway

Location

MeSH Terms

Conditions

Osteoarthritis, HipMotor Activity

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ottar Vasseljen

    NTNU, Medisink fakultet, Institutt for samfunnsmedisin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations