NCT03828240

Brief Summary

Objectives: To evaluate the feasibility of a HIP fracture REhabilitation Programme (HIP-REP).This study will investigate adherence, satisfaction, technical and practical circumstances regarding implementation and taking this into account when evaluating the feasibility of the HIP-REP program. Hypothesis: By testing the feasibility of a HIP-REP for the participants and the usefulness of the selected measurement tools, the investigators will be able to evaluate and adjust the HIP-REP before evaluating this in a larger Randomized controlled trial (RCT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

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

January 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

January 29, 2019

Last Update Submit

September 5, 2019

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • Assessment of Motor and Process Skills

    The assessment measures the quality of a person's activity of daily living task performance. An observational assessment that allows for evaluation of change in motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living. The instrument consists of 16 motor and 20 process skill abilities that are rated on a 4-point scale, In all, 36 discrete ratings of motor and process skills are made during observation.

    Change from baseline at motor and process skills 3 months after baseline testing

Secondary Outcomes (7)

  • European Quality of Life Questionnaire

    at baseline and 3 months after baseline testing

  • Verbal Rating Scale

    at baseline and 3 months after baseline testing

  • Occupational Balance Questionnaire

    at baseline and 3 months after baseline testing

  • Satisfaction with daily occupations

    at baseline and 3 months after baseline testing

  • Cumulated Ambulation Score

    at baseline

  • +2 more secondary outcomes

Study Arms (1)

Enhanced rehabilitation

OTHER
Other: HIP fracture REhabilitation Programme for the elderly with hip fractures

Interventions

HIP fracture REhabilitation Programme for the elderly with hip fracturesOTHER

Eight-week activity-based intervention for elderly with hip fractures; one intervention during the hospital stay, four interventions at the elderly's municipality.

Enhanced rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Aged 65 years or older
  • Recent proximal hip fracture (S 72.0 Medial femur fracture, S 72.1, Pertrochanteric femur fracture, S 72.2 Subtrochanteric femur fracture)
  • Living at home prior to hip fracture in Herlev, Gentofte or Lyngby-Taarbæk municipalities
  • Ability to give informed consent
  • Discharged from hospital and receiving or having received rehabilitation in one municipalities within the last 3 months from onset

You may not qualify if:

  • Not expected to be discharged to home or rehabilitation centers in the municipality
  • Not able to speak and/or understand Danish
  • Have prior severe physical and /or mental disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte

Copenhagen, Herlev, 2730, Denmark

Location

Related Publications (2)

  • Ropke A, Morville AL, Moller TE, Delkus ECG, Juhl CB. HIP Fracture REhabilitation Program for older adults with hip fracture (HIP-REP) based on activity of daily living: a feasibility study. BMC Geriatr. 2022 Apr 27;22(1):370. doi: 10.1186/s12877-022-03039-x.

    PMID: 35477380DERIVED

  • Ropke A, Lund K, Thrane C, Juhl C, Morville AL. Developing an individualised cross-sectoral programme based on activities of daily living to support rehabilitation of older adults with hip fracture: a qualitative study. BMJ Open. 2021 Jun 18;11(6):e044539. doi: 10.1136/bmjopen-2020-044539.

    PMID: 34145009DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Activity-based intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2019

First Posted

February 4, 2019

Study Start

February 1, 2019

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)