NCT01972594

Brief Summary

Total hip replacement is designed to alleviate pain, reduce disability and improve function and physical activity levels. Whilst pain, disability and function are often measured following surgery, actual physical activity is not. The aim of rehabilitation after total hip replacement would be to obtain optimal strength and range of movement at the hip along with cumulative endurance and balance. It is taken for granted that, once function is restored, the patient returns to physical activity levels associated with good health. In a previous study conducted by the same team it was observed that patients, at the end of 3 months after hip surgery, do not reach the levels of physical activity which are proven to be beneficial for health. Physiotherapy plays an important role in improving function and increasing levels of Physical activity in total hip replacement patients, but there is limited literature to substantiate this claim. There is a need to enhance levels of physical activity in patient after total hip replacement towards levels that are associated with good health. This study aims to demonstrate a method of enhancing physical activity levels after total hip replacement using a pedometer based intervention over a period of 3 months. Patients will follow a customized progressive stepping activity schedule aimed at establishing levels of physical activity that are associated with good health. To fully understand recovery patterns subjective and objective measures of strength of the hip muscles, range of motion at the hip, overall endurance, balance and speed of walking of the patient will be assessed. Questionnaires will be utilized to assess quality of life both before and after total hip surgery. The physical activity levels of the patient will be measured with a physical activity monitor. This study will be completed at the Golden Jubilee National Hospital at Glasgow.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 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

First Submitted

Initial submission to the registry

October 16, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

October 16, 2013

Last Update Submit

March 12, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Physical Activity following Hip Replacement.

    Free-living physical activity performance will be recorded using an Accelerometer(ActivPAL).A small CE marked physical activity monitor, ActivPAL (PAL Technologies Ltd. Glasgow, UK) will be attached to the anterior thigh (of the non-operated leg) using a water proof surgical dressing material. This monitor, with proven validity is 50mm x 35mm x 7mm and weighs 30g. The fixing with the dressing allows it to be worn continually without affecting any patient activity such as washing / showering etc. This remains in place for the duration of the recording. It can record date for up to 7 days. The time spent upright, time spent stepping and the numbers of steps taken are recorded continuously over multiday periods. The intervention group will be encouraged to increase their physical activity levels. This will be based on a measure of stepping activity and a pedometer will act as a guideline for how many steps are required per day.

    pre-operative,Immediate post -operative,1st week post operative and 3 months post operative.

Study Arms (2)

Control group.

NO INTERVENTION

Natural progession based on Step count is recorded with a pedometer for 12 weeks.

Targeted protocol with Pedometer

EXPERIMENTAL

A step based targeted protocol is given along with a pedometer for 12 weeks post surgery.

Procedure: Targetted protocol with pedometerDevice: Accelerometer(ActivPAL)

Interventions

12 week protocol based on targetted steps are given to the patient along with a pedometer.

Targeted protocol with Pedometer
Targeted protocol with Pedometer

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary total hip replacement
  • Age group between 60-80 years old.
  • Able to give informed consent
  • Able to return for follow-up
  • Able to read and understand English and follow verbal and visual instructions

You may not qualify if:

  • Bilateral total hip replacements
  • Either hip or knee replacement in the last 12 months
  • Severe locomotor limitation due to cardio-respiratory dysfunction
  • Severe locomotor disorder due to central or peripheral nervous system deficits
  • Severe locomotor limitation due to spinal condition
  • Severe locomotor limitation due to musculoskeletal disabilities
  • Diagnosed terminal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Glasgow,Scotland, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Academic Supervisor to the Chief Investigator of the Study

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 30, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations