Rocking Chairs as Post-operative Treatment for Older Adults After Hip Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Missouri, Kansas City

About this trial

Feasibility and acceptability randomized controlled trial exploring the use of a rocking chair after a total hip arthroplasty in adults who are aged 65 or older. Primary aims include its feasibility and acceptability; exploratory aims include the impact of rocking on pain, gastrointestinal effects, anxiety, ambulation, and additional healthcare visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

scheduled to undergo an elective primary total hip arthroplasty

Weigh less than 163kg (limit of rocking chair)

Able to consent

Able to rock with at least one leg

Disqualifiers

Unable to sit in a chair for at least 30 minutes at a time

Hospitalized more than 24 hours after surgery

Cannot read and understand the English language

Planned disposition to rehabilitation facility or skilled nursing facility

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active rocking in a rocking chair

    Behavioral

    Participants will actively rock 3 times per day for 30 minutes in a rocking chair

  • Sitting upright in a stationary chair

    Behavioral

    Participants will sit upright in a stationary chair 3 times per day for 30 minutes

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Attention Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants that enroll and complete study assessed by Feasibility Participant Questionnaire (developed by investigators)

Feasibility of active rocking post-operative measured by total number of participants enrolled, total percentage and number completing the study, and percent of missing data. A higher percent of missing data is a negative outcome.

Time frame
From enrollment to 31-day follow-up
2

Total participants reporting acceptability of rocking or sitting as measured by Acceptability for Participants Questionnaire

Acceptability of rocking or sitting after hip arthroplasty indicated by score on domains of affective, perceived effectiveness, intervention coherence, ethicality, burden, opportunity costs, self-efficacy likert scales from 1-4 (Not at all, a little, somewhat, very much). Scores from each domain are combined and summed to determine a single acceptability score (higher scores equate to higher acceptability of the intervention).

Time frame
From enrollment to 31-day follow-up

Secondary outcomes

1

Total participants indicating Nausea using the PROMIS Scale v1.0 GI Nausea and Vomiting 4A

Participants indicate Daily nausea assessment on 5-point Likert scale (never, rarely, sometimes, often, always). Higher scores indicate more Nausea.

Time frame
From surgery (Day 1 of the study) to 31-day follow-up
2

Total participants reporting Gas/bloating via PROMIS v1.1 GI Gas and Bloating 13A

Participants reporting Daily gas/bloating assessment on 5-point Likert scale (not at all, a little bit, somewhat, quite a bit, very much). Higher scores indicate more daily gas/bloating.

Time frame
From surgery (Day 1 of the study) to end of 31-day follow-up
3

Total participants reporting Daily pain assessed by PROMIS v2.0 pain intensity 3A

Participants reporting Daily pain assessment on 5-point likert scale (no pain, mild, moderate, severe, very severe). Higher scores equate to more daily pain experienced.

Time frame
From surgery (Day 1 of the study) to end of 31-day follow-up
4

Total amount of participants' Daily Ambulation as measured using steps via activPAL4pro accelerometer

The amount of participants' Daily ambulation will be assessed with the amount of steps taken per day using the triaxial accelerometer activPAL4pro. More steps per day equates to greater ambulation.

Time frame
After surgery (Day 1 of the study) and up to 7 days post-surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Missouri, Kansas City

Lead sponsor

Sigma-Tau Research, Inc.

Collaborator

Association of Rehabilitation Nurses

Collaborator

This trial is not recruiting at the moment. You can still explore other options: