NCT01700933

Brief Summary

Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability. The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a well-documented effect on pain and function in patients with osteoarthritis of the hip. It is sought an optimal dose of exercise, in which this study will help to investigate. We hypothesize that an exercise program designed to have a high number of repetitions will benefit the outcome of the training in a more positive way than a low-repetition based program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

October 1, 2012

Last Update Submit

September 19, 2017

Conditions

Osteoarthritis, Hip

Keywords

Exercise therapy

Outcome Measures

Primary Outcomes (1)

  • WOMAC Index of Osteoarthritis (questionnaire)

    WOMAC Index of Osteoarthritis (questionnaire)

    0 weeks, 8 weeks, 6 months postinterventional

Secondary Outcomes (4)

  • HAD questionnaire

    0 weeks, 8 weeks, 6 months postinterventional

  • Tampa Scale for Kinesiophobia

    0 weeks, 8 weeks, 6 months postinterventional

  • Squats

    0 weeks, 8 weeks, 6 months postinterventional

  • Stairs

    0 weeks, 8 weeks, 6 months postinterventional

Study Arms (2)

High-dosage-group

ACTIVE COMPARATOR
Other: High-Dosage Exercise Therapy

Low-dosage-group

ACTIVE COMPARATOR
Other: Low-Dosage Exercise Therapy

Interventions

High-Dosage Exercise TherapyOTHER

Structure of the exercise program done three times per week, for eight weeks: 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)

High-dosage-group
Low-Dosage Exercise TherapyOTHER

Structure of the exercise program done three times per week, for eight weeks: 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)

Low-dosage-group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least three month since debut of the disease
  • Age above 45 years
  • Ability to complete the intervention

You may not qualify if:

  • Pain above 4 on VAS during gait
  • Pregnancy
  • Autoimmune disease
  • Cardiovascular disease
  • Respiratory disease
  • Metabolic disease
  • Neurological signs
  • Planned hip-replacement surgery within the next year
  • Received exercise therapy within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fysioterapitjenesten i Ørsta

Ørsta, 6154, Norway

Location

Related Publications (1)

  • Osteras H, Paulsberg F, Olsen SE, Osteras B, Torstensen TA. Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study. J Bodyw Mov Ther. 2017 Apr;21(2):284-289. doi: 10.1016/j.jbmt.2016.06.016. Epub 2016 Jul 5.

    PMID: 28532870RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Håvard Østerås

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 4, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations

NO(1)