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Prehabilitation Using Aquatic Exercise

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

Tracking Information
First Submitted Date  ICMJE May 9, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date January 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prehabilitation Using Aquatic Exercise
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Behavioral: Aquatic Prehab
Pool therapy
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2017)
44
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2016)
40
Actual Study Completion Date  ICMJE January 19, 2018
Actual Primary Completion Date January 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773745
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sunghye Kim, MD Wake Forest Baptist Medical Center
PRS Account Wake Forest University Health Sciences
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP