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Clinical Trials/NCT04859309
NCT04859309
Unknown
Not Applicable

Activating Older People After a Hip Fracture

Universidad de Granada1 site in 1 country104 target enrollmentJune 1, 2021
ConditionsHip Fractures

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
Universidad de Granada
Enrollment
104
Locations
1
Primary Endpoint
Short Physical Performance Battery (SPPB)
Last Updated
4 years ago

Overview

Brief Summary

The main aim of this study is to determine if the ActiveHip tele-rehabilitation mobile application improves the functional level and the quality of life of patients who undergone hip surgery after a fracture.

The second aim is to determine if the ActiveHip intervention reduce the anxiety, stress and burden of the caregivers.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrocinio Ariza Vega

Principal investigator

Universidad de Granada

Eligibility Criteria

Inclusion Criteria

  • Have hip fracture surgery
  • Age equal to or greater than 65 years
  • Are allowed weight-bearing at 48 hours after surgery
  • Had a high pre-fracture functional level the week before the fracture (Functional Independence Measure \[FIM\] index scored more than 90 points)
  • Have an informal or family caregiver who has the ability to access the Internet to use the app ActiveHip+
  • Basic management of the mobile phone
  • Have signed an informed consent.

Exclusion Criteria

  • Presence of low cognitive level (Pfeiffer test score lower than 4 points)
  • Being dependent on the activities of daily living before the hip (Functional Independence Measure \[FIM\] index scored less than 60 points)
  • Being institutionalized
  • Post-surgery complications
  • Terminal disease
  • Age under 65 years

Outcomes

Primary Outcomes

Short Physical Performance Battery (SPPB)

Time Frame: The primary outcome will be followed over 12 weeks.

The SPPB is one of the most commonly used instruments for measuring physical performance in population studies. The SPPB assessment has previously been used to evaluate the mobility of older people and patients with a hip fracture. The performance battery consists of three tasks: balance, walking, and chair stands. The SPPB tests of balance, including time to walk 4 meters and time required to stand from a chair 5 times. The score ranges from 0 to 12 points, with higher scores indicating better mobility. Low scores on the SPPB have a high predictive value for a wide range of health consequences including disability in Activities of Daily Living, loss of mobility, disability, hospitalization duration of stay in the hospital, admission to nursing facilities, and death. Internal consistency is high, with Cronbach's α = 0.87.

Secondary Outcomes

  • Visual Analogue Scale for Pain (VAS Pain)(12 weeks)
  • EuroQoL 5D Quality of Life questionnaire(12 weeks)
  • Functional Independence Measure(12 weeks)
  • New Mobility Score (NMS)(12 weeks)
  • Short Falls Efficacy Scale-International (SFES-I)(12 weeks)
  • International Fitness Scale (IFIS)(12 weeks)
  • The Short Portable Mental State Questionnaire (SPMSQ) of Pfeiffer(12 weeks)
  • The Hospital Anxiety and Depression Scale (HADS)(12 weeks)
  • Zarit Burden Interview(12 weeks)
  • The Low Back Pain Disability Scale (Oswestry)(12 weeks)

Study Sites (1)

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