Osteoarthritis, KneeNCT02773745
Prehabilitation Using Aquatic Exercise
A study testing Aquatic Prehab in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Aquatic Prehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 19 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Unit
Winston-Salem, North Carolina, 27157
About this study
Official title: The Effects of Aquatic Prehabilitation in Knee OA Patients on Knee Arthroplasty Outcomes
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Aquatic Prehab
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic PrehabBehavioural
Pool therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participant will receive standard of care and a brochure on healthy eating. |
| Aquatic Prehabilitation Group | Active comparator | 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. Receives: Behavioral: Aquatic Prehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 4-6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startApr 2016
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunghye Kim, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773745
- Sponsor's protocol ID
- IRB00032580
- Status last verified
- Jun 2019
- First submitted
- 9 May 2016
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aquatic Prehabilitation in Knee OA Patients on Knee Arthroplasty Outcomes
- ClinicalTrials.gov ID
- NCT02773745
- Acronym / sponsor ID
- IRB00032580
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participant will receive standard of care and a brochure on healthy eating. |
| Aquatic Prehabilitation Group | Active comparator | Behavioral: Aquatic PrehabThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic PrehabPool therapy | Behavioural | Aquatic Prehabilitation Group |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunghye Kim, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Prehab in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical function using the MAT-sf (time frame: 4-6 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.