Prehabilitation Using Aquatic Exercise
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquatic Prehab
Sponsored by
About this trial
This is an interventional supportive care trial for Osteoarthritis, Knee
Eligibility Criteria
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:
- 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
Sites / Locations
- Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard of Care
Aquatic Prehabilitation Group
Arm Description
Participant will receive standard of care and a brochure on healthy eating.
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.
Outcomes
Primary Outcome Measures
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)
Change in physical function using the eSPPB
Change in eSPPB score from baseline (prior to surgery) to follow up (4-6 weeks after surgery)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02773745
First Posted
May 9, 2016
Last Updated
June 12, 2019
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02773745
Brief Title
Prehabilitation Using Aquatic Exercise
Official Title
The Effects of Aquatic Prehabilitation in Knee OA Patients on Knee Arthroplasty Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
January 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participant will receive standard of care and a brochure on healthy eating.
Arm Title
Aquatic Prehabilitation Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aquatic Prehab
Intervention Description
Pool therapy
Primary Outcome Measure Information:
Title
Change in physical function using the MAT-sf
Description
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
Title
Change in physical function using the eSPPB
Description
Change in eSPPB score from baseline (prior to surgery) to follow up (4-6 weeks after surgery)
Time Frame
4-6 weeks after surgery
Title
Change in physical function using the Postural Sway Force Plate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunghye Kim, MD
Organizational Affiliation
Wake Forest Baptist Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prehabilitation Using Aquatic Exercise
We'll reach out to this number within 24 hrs