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Group Exercise After Hip Replacement Surgery

This study has been terminated.
(recruitement unsuccessful)
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01253798
First received: December 2, 2010
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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?


Condition Intervention
Osteoarthritis, Hip
 Other: Group training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: What Type of Group Exercise Should be Chosen for Osteoarthritis Patients in the Rehabilitation Phase Following Hip Replacement Surgery?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Function1 [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).

  • Function2 [ Time Frame: Post-operative ] [ Designated as safety issue: No ]
    Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).

  • Funtion3 [ Time Frame: After 12 weeks training ] [ Designated as safety issue: No ]
    Function is evaluated using a questionnaire, Harris Hip Score (HHS) and by using 6-minute walk test (6MWT).


Secondary Outcome Measures:
  • Muscle strength1 [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    Muscle strength around the operated hip are evaluated by measuring isometric muscle strength in hip-abduction and knee-extension using a hand-held dynamometer (HHD) from Lafayette Instruments.

  • Muscle strength2 [ Time Frame: Post-operative ] [ Designated as safety issue: No ]
    Muscle strength around the operated hip are evaluated by measuring isometric muscle strength in hip-abduction and knee-extension using a hand-held dynamometer (HHD) from Lafayette Instruments.

  • Muscle strength3 [ Time Frame: After 12 weeks training ] [ Designated as safety issue: No ]
    Muscle strength around the operated hip are evaluated by measuring isometric muscle strength in hip-abduction and knee-extension using a hand-held dynamometer (HHD) from Lafayette Instruments.


Enrollment: 19
Study Start Date: November 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group training on land
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
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.
Active Comparator: Group training in water
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
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who experience serious complications after surgery
  • if a person has a disease that causes that one can not complete the planned training
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253798

Locations
Norway
St. Olavs Hospital, department Orkdal
Orkanger, Sør-Trøndelag, Norway, 7030
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Ottar Vasseljen NTNU, Medisink fakultet, Institutt for samfunnsmedisin
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01253798     History of Changes
Other Study ID Numbers: NTNU-ISM-KH-2010
Study First Received: December 2, 2010
Last Updated: September 19, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Norwegian University of Science and Technology:
exercise
hydrotherapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013