Prehabilitation Using Aquatic Exercise

• ClinicalTrials.gov Identifier: NCT02773745
• Recruitment Status: Completed
• First Posted: May 16, 2016
• Last Update Posted: June 13, 2019
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Tracking Information

• First Submitted Date: May 9, 2016
• First Posted Date: May 16, 2016
• Last Update Posted Date: June 13, 2019
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: January 19, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 13, 2016)

• Change in physical function using the MAT-sf [ Time Frame: 4-6 weeks after surgery ]
  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 [ Time Frame: 4-6 weeks after surgery ]
  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 [ Time Frame: 4-6 weeks after surgery ]
  Change in postural sway score from baseline (prior to surgery) to follow up (4-6 weeks after surgery)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prehabilitation Using Aquatic Exercise
• Official Title: The Effects of Aquatic Prehabilitation in Knee OA Patients on Knee Arthroplasty Outcomes
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Supportive Care
• Condition: Osteoarthritis, Knee

Intervention

Behavioral: Aquatic Prehab

Pool therapy

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.
  Intervention: Behavioral: Aquatic Prehab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2017): 44
• Original Estimated Enrollment (submitted: May 13, 2016): 40
• Actual Study Completion Date: January 19, 2018
• Actual Primary Completion Date: January 19, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02773745
• Other Study ID Numbers: IRB00032580
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Wake Forest University Health Sciences
• Study Sponsor: Wake Forest University Health Sciences
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sunghye Kim, MD; Wake Forest Baptist Medical Center

• PRS Account: Wake Forest University Health Sciences
• Verification Date: June 2019