Hip Fracture Exercise and Rehabilitation Post Hip Fracture Study

NCT03247205 | Withdrawn DMC

• 1 other identifier: HP-00073627
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will look at whether it is possible to give better physical therapy to people with cognitive limitations who have had a hip fracture.

Conditions

Hip Fractures; Cognitive Impairment

Keywords

hip fracture; cognitive impairment; physical therapy

Outcome Measures

Primary Outcomes (3)

• Feasibility of the Intervention

  Data regarding feasibility will include numbers of participants contacted, enrolled, drop-outs/withdrawals, and completing intervention and the number of adverse events.

  6 weeks

• Feasibility of the Intervention (time)

  Data regarding feasibility will include total time to implement the intervention.

  6 weeks

• Treatment Fidelity

  Treatment fidelity of the intervention will include recording of adherence and logs of intervention tasks and problems regarding barriers to implementation of the intervention and open-ended interviews with caregivers about their experiences with the intervention.

  6 weeks

Secondary Outcomes (7)

• Short Physical Performance Battery (SPPB)

  6 weeks

• Barthel Index for Activities of Daily Living

  6 weeks

• Lower Extremity Gain Scale (LEGS)

  6 weeks

• Neuropsychiatric Inventory (NPI)

  6 weeks

• Zarit Burden Interview

  6 weeks

Study Arms (1)

HipERS

EXPERIMENTAL

A trained physical therapist will visit each participant for a 1-hour session 3 times a week for the initial 2 weeks, and then 2 times a week for 4 weeks (total 14 hours over 6 weeks).

Behavioral: HipERS

Interventions

HipERS BEHAVIORAL

This is a graduated, functionally-based exercise intervention conducted in the participant's home. The intervention incorporates verbal encouragement and positive reinforcement, role modeling, assessment of and elimination of unpleasant sensations associated with an activity, and confidence building through activity repetition. The exercise component includes 1) strengthening exercises, 2) range of motion exercises, 3) balance training, 4) functional training, such as chair rising, ambulation training, and stair climbing, 5) transfer practice, 6) adjusting walking aides, and 7) adapting and modifying environment; with a focus on lower extremity tasks in all these areas.

HipERS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Hip fracture
• Age 65+ at time of fracture
• Had surgical repair for the hip fracture
• Completed usual rehabilitation
• Discharged to the community after rehabilitation ends (i.e., private home or assisted living)
• Cognitive limitation (MoCA score 18-25)

You may not qualify if:

• Pathologic fracture
• Not community-dwelling (e.g., nursing home resident) prior to fracture
• Bedbound during the 6 months prior to fracture
• Not returning to the community before 180 days post-hospital discharge (can go to assisted living)
• Not authorized by a physician to participate in an exercise or rehabilitation program prior to starting the intervention
• Gait speed of greater than 0.8 m/s (already walking well) at baseline
• Caregiver Participant
• Identified as a caregiver (i.e., family relative or non-relative, unpaid or paid, informal or formal) who will help or supervise the hip fracture participant with ADL or IADL tasks after discharge from rehab
• Helping or supervising the hip fracture participant with one or more ADL or IADL tasks at least weekly when screened for this study OR plans to be the primary person providing care at least weekly after the hip fracture participant is discharged from rehab
• Not English speaking
• Living more than 40 miles from the hip fracture participant
• Unable to provide informed consent

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Hip Fractures; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ann Gruber-Baldini, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants will receive the intervention

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: August 1, 2018
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: March 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)