'Rehabilitation for Life'

NCT04424186 | Completed

• 1 other identifier: SLB-Phys-06-2020
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

Brief Summary

Despite implementing hospital quality programs after hip fracture surgery older adults often experience a decline in the level of physical function, reduced quality of life; and the mortality and readmission rates are high. Early mobilization is important in order to prevent loss of muscle mass; however to prevent morbidity an early start of strength training is also necessary. Furthermore, the risk of complications, morbidity, and mortality are associated with insufficient management of pain. The project aims to examine the effect of measuring vital signs and consistent rehabilitation in the primary and secondary sectors in older adults after hip fracture surgery. Method/ design: The study is a cluster-randomized stepped wedge study. Participants will be recruited among patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in one of six municipalities. Participants are also the health professionals in the orthogeriatric ward and the six municipalities. The six municipalities form six clusters, which are randomized, and every three-month one cluster cross from control to intervention. The study compares usual practice (control) to an intervention named 'Rehabilitation of Life'. An intervention best described as an empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation and combined with convenient access for collaboration among professionals. Primary outcomes: Timed Up and Go (TUG) measured 2 months after the time of operation. The investigators hypothesize that 'Rehabilitation of Life' for older adults with a hip fracture will result in a significant reduced TUG-score in comparison to a practice not offering 'Rehabilitation of Life'. And as the study is organised across two sectors, the Cumulated Ambulation Score (CAS) makes a second primary outcome. It is hypothesised that patients in the intervention group will achieve a significantly reduced TUG score compared to usual care.

Conditions

Hip Fractures

Keywords

Rehabilitation; cross-sectorial cooperation; older

Outcome Measures

Primary Outcomes (2)

• Timed up and go

  Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome

  Two months after the time of operation

• Cumulated Ambulation Score (CAS)

  Measures basic mobility. The score 0-6. Higher scores mean a better outcome

  One months after the time of operation

Secondary Outcomes (2)

• Timed up and go

  Three and six months after the time of operation

• Barthel-20

  2, 3, 6 and 12 months after the time of surgery

Other Outcomes (3)

• Eq-5D

  2, 3, 6 and 12 months after the time of surgery

• Mortality 30 days and 1 year.

  Mortality measured after 30 days and one year

• Readmission

  Readmission measured 30 days after discharge

Study Arms (2)

'Rehabilitation for Life'

EXPERIMENTAL

Vital sign measurement and rehabilitation

Other: 'Rehabilitation for Life'

Usual care and rehabilitation

ACTIVE COMPARATOR

Usual care and rehabilitation provided in primary and secondary sectors

Other: Usual care and rehabilitation

Interventions

'Rehabilitation for Life' OTHER

An empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation combined with convenient access for collaboration among professionals.

'Rehabilitation for Life'

Usual care and rehabilitation OTHER

The care and rehabilitation usual provided to patients after hip fracture surgery

Usual care and rehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with a hip fracture
• Patients of 65 years of age or older
• Patients admitted to an orthogeriatric ward
• Patient who are citizens in one og three municipalities

You may not qualify if:

• Patients discharged for permanent residence in nursing homes
• Patients who cannot participate in a conversation
• Terminal registered patients.

Sponsors & Collaborators

• Kolding Sygehus: lead

Study Sites (1)

Inge Bruun

Kolding, Southern Denmark, 6000, Denmark

Location

Related Publications (1)

• Ipsen JA, Pedersen LT, Viberg B, Norgaard B, Suetta C, Bruun IH. Rehabilitation for life: the effect on physical function of rehabilitation and care in older adults after hip fracture-study protocol for a cluster-randomised stepped-wedge trial. Trials. 2022 May 7;23(1):375. doi: 10.1186/s13063-022-06321-w.

  PMID: 35526010 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Inge Bruun, post doc

  The Region of Southern Denmark and University of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cluster-randomized stepped wedge study. A design that is initiated with a period without interventions followed by a form of cross-over, in which each cluster systematic cross from control to intervention.

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: September 22, 2020
• Primary Completion: April 9, 2023
• Study Completion: February 9, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)