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CompletedNCT02773745Updated Jun 13, 2019

Prehabilitation Using Aquatic Exercise

An interventional study of Aquatic Prehab in Osteoarthritis, Knee, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-13.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
50 Years and older
Sex
All
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Study summary

With aging population, total knee arthroplasty is performed with increasing frequency. Although the surgery is successful in general, significant number of patients suffers persistent pain and disability. Traditional risk assessment tool have been focused on single organ systems. Our investigators have found that mobility, assessed by the Mobility Assessment Tool short form (MAT-sf), is a simple and accurate method to predict postoperative outcome, including length of stay, postoperative complications, and nursing home placement for older patients. Prehabilitation is the process of enhancing a person's functional capacity to withstand an incoming stressor. Although multiple studies have tested prehabilitation before joint replacement surgery, results have been mixed. The investigators hypothesize that patients with limited mobility are most likely to benefit from prehabilitation. The investigators plan to use individualized aquatic exercise as a prehabilitation tool to enhance compliance; the resistance of water strengthen muscle and increasing energy expenditure; the buoyancy of water provides environment where the joints are not weight bearing. The aims of the study are: 1) To evaluate the feasibility of prehabilitation using 6-8 weeks of aquatic exercise in 40 geriatric patients who are scheduled for total knee arthroplasty for osteoarthritis; 2) To examine the effects of 6-8 weeks of aquatic exercise on mobility, pain, stiffness, physical function, cognitive function and depression; inflammatory markers and 3) To estimate the effect of prehabilitation on postoperative outcomes. The investigators plan to enroll 40 patients age >50, who are scheduled for elective primary total knee replacement. Investigators will screen patients in the Preoperative Assessment Clinic and enroll patients who have decreased mobility, measured by MAT-sf. Patients will be randomized into either a prehabilitation group or a usual care group. All the participants will undergo extensive assessment on their pain, stiffness, and physical function, depression, balance and cognitive function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the expanded Short Physical Performance Battery (eSPPB), and Montreal Cognitive Assessment (MoCA). Serum inflammatory markers will be assessed at the baseline. The prehabilitation group will undergo 6-8 weeks of individualized aquatic exercise in a heated pool (60 min/session, 3 times per week). Aquatic equipment maybe used to challenge balance and trunk stabilization. All participants will be reassessed immediately before surgery and 4 weeks after the surgery using WOMAC, eSPPB, MoCA and MAT-sf. Serum inflammatory markers and body composition will be reassessed at the same time points. The primary outcome of interest is will be postoperative complications, length of stay, Intensive Care Unit length of stay, and institutionalization. If successful, investigators will have sound pilot data for several critical health outcomes with which to support an external proposal for a larger-scale study.

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Conditions studied

  • Osteoarthritis, Knee
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In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 44 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 199 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed Informed Consent
  • Age > 50
  • Willingness to exercise in a pool 3 times a week
  • MAT-Sf score ≤ 58 for men and ≤ 50 for women
  • Participant is scheduled for primary total knee replacement surgery due to OA >4 weeks from expected BV visit
  • Not involved in any other behavioral, exercise or investigational drug intervention study

Exclusion criteria

Exclusion Criteria:

  • Impaired cognitive function (MoCA \<21)
  • Undergoing knee replacement surgery for indications other than OA
  • Undergoing bilateral knee replacements
  • Major deficits in hearing or vision
  • Currently exercising more than 3 times per week
  • Severe depression (GDS-sf ≥ 12)
  • Contraindications to the pool: open wounds/ incontinence/history of seizures in last year
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
44 participants (actual)

Study arms

  • No intervention
    Standard of Care

    Participant will receive standard of care and a brochure on healthy eating.

  • Active comparator
    Aquatic Prehabilitation Group

    The prehabilitation group will undergo 6-8 weeks of individualized aquatic exercise in a heated pool (60 min/session, 3 times per week). Aquatic equipment maybe used to challenge balance and trunk stabilization.

    Behavioral: Aquatic Prehab

Interventions

  • BehavioralAquatic Prehab

    Pool therapy

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What researchers measure

Primary outcomes

  1. Change in physical function using the MAT-sf

    Change in MAT-sf score from baseline (prior to surgery) to follow up (4-6 weeks after surgery)

    Time frame: 4-6 weeks after surgery

  2. Change in physical function using the eSPPB

    Change in eSPPB score from baseline (prior to surgery) to follow up (4-6 weeks after surgery)

    Time frame: 4-6 weeks after surgery

  3. Change in physical function using the Postural Sway Force Plate

    Change in postural sway score from baseline (prior to surgery) to follow up (4-6 weeks after surgery)

    Time frame: 4-6 weeks after surgery

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Study locations

1 site
  • Clinical Research Unit
    Winston-Salem, North Carolina 27157, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02773745
Responsible party
Sponsor
First posted
May 16, 2016
Start date
Apr 2016
Primary completion
Jan 19, 2018
Completion
Jan 19, 2018
Last update
Jun 13, 2019

Study contacts

Sunghye Kim, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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