NCT02815254

Brief Summary

The focus of this project are elderly people who have experienced hip fracture and need at least two weeks rehabilitation after discharge from hospital. The aim is to increase the evidence-based knowledge base for planning and appropriate follow-up intervention for patients with hip fracture on short-term / rehabilitation stays. In this study the investigators want to explore whether training High Intensity Functional Exercises (HIFE) , of short duration ie a 2- 4 week program and frequent intervention ie 5 times per week has a significant positive effect on physical function, pain and quality of life. The main aim is to explore whether a high intensive strength and balance training program has better effect than a low intensive strength and balance training program on functional status measured by Short Physical Performance Battery (SPPB) in patients with hip fractures. Another aims is to explore whether this high intensive strength and balance training program has better effect than a 'low intensive strength and balance training program' on pain, endurance and quality of life measured respectively Numeric Pain Rating Scale (NPR), 6-minute walk test and SF-36. The study is a randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 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

April 21, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

5.9 years

First QC Date

April 21, 2015

Last Update Submit

October 5, 2022

Conditions

Keywords

Physiotherapyhip fracturerehabilitationhigh dose exerciselow dose exercise

Outcome Measures

Primary Outcomes (1)

  • The Short Physical Performance Battery

    November 2015 -October 2018 (up to 3 years)

Study Arms (2)

Low dose exercise intervention

ACTIVE COMPARATOR
Other: Low intensity functional exercise

High dose exercise intervention

EXPERIMENTAL
Other: High intensity functional exercise

Interventions

High dose exercise intervention
Low dose exercise intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Fractura colli femoris, pertrochantar or subtrochantar)
  • Discharged from hospital within 3 weeks since surgery.
  • Need of minimum two weeks rehabilitation
  • Life expectancy of more than one month
  • Able to walk at least 3 m with walking aid
  • Willingness to participate
  • Able to follow instructions
  • years or older

You may not qualify if:

  • Other reasons for gait impairment than hip fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Braseth rehabilitation centre

Røyken, 3440, Norway

Location

Related Publications (1)

  • Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Astrid Bergland, PhD

    Oslo Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2015

First Posted

June 28, 2016

Study Start

November 1, 2015

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations