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PARQUE 70+ Studying Sleep Disorder

Primary Purpose

Osteoarthritis, Sleep Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PARQVE Program
Geriatric Care
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Quality of Life, Sleep disorder

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Classified as Kelgreen and Lawrence grades I to III (K-L), ie any degree of gonarthritis without obliteration of the joint space;
  • Indication of clinical treatment of OA;
  • Patients without moderate to advanced dementia syndrome;
  • Patients without neuropsychiatric diseases whose symptoms may impair the assimilation of the given guidelines.

Exclusion Criteria:

  • Missing interventions and not performing the tasks determined by professionals;
  • Patients with low family support;
  • Prescription in the last three months, during the study, some type of hypnotic or sleep inducing medication, which may interfere with the study analysis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental

    Control

    Arm Description

    30 Patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy team followed by 7 sessions with the physical educators team (once a week/4 weeks and once every two weeks, three times).

    Should remain under geriatric care after randomization.

    Outcomes

    Primary Outcome Measures

    Evaluate changes in the quality of sleep after the multiprofessional intervention
    Answer questionnaires about sleep disorders - Ranges Min: 0 Better - Max: 24 Worse

    Secondary Outcome Measures

    Change of the insomnia severity index
    Answer insomnia severity index - Ranges Min: 0 Better - Max: 24 Worse
    Change of the Epworth Sleepiness Scale
    Answer Epworth Sleepiness Scale - Ranges Min: 0 Better - Max: 24 Worse
    Change of the subjective complaint of perception of sleep
    Answer the subjective complaint of perception of sleep - Ranges Min: 0 Better - Max: 24 Worse
    Change in the amount of pain medication
    Take notes day by day amount of medication

    Full Information

    First Posted
    August 14, 2019
    Last Updated
    August 19, 2019
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04059419
    Brief Title
    PARQUE 70+ Studying Sleep Disorder
    Official Title
    PARQUE 70+ Studying Sleep Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    February 28, 2020 (Anticipated)
    Study Completion Date
    May 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The emerging Brazilian population is accompanied by the emergence of patients in an age group, including osteoarthritis. Osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases, affecting 4% of the Brazilian population. By 2050, 30% of Brazil's population is over 60 years old. This has a higher degree of elderly with morbades as unbass on the association, such as osteoarthritis. Proper management of OA involves educational program, multidisciplinary team care and therapeutic maneuvers with weight loss and maintenance of mobility. Insomnia is the most frequent sleep disorder in the elderly and its execution almost always harms young women. Sleep quality is interfered with fatigue and pain exacerbation in people with OA, ie a sleep approach should be diagnosed in patients with comorbidity. In addition, chronic patients usually have insomnia and pressure in the use of opioids, sedatives and antidepressants, pointing to insomnia and mood swings for polypharmacy. To evaluate a quality of sleep as an intervention of the PARQVE 70+ Project. Prospective, case-control study. Patients over 70 years old treated at a geriatric outpatient clinic with eye or polyarticular osteoarthesis and clinical OA treatment indicator will be allocated and matched in two groups of 30 elderly. Patients underwent Pittsburgh Sleep Quality Index questionnaires and the Epworth Scale before the study began, 3 and 6 months after PARQVE interventions and number of analysts, and compared those who did not perform an intervention. The study aims to improve sleep quality, decrease pain, reduce quality and decrease daytime sleepiness in elderly with OA.
    Detailed Description
    The growing Brazilian population aging is accompanied by the emergence of common diseases in this age group, including osteoarthritis. Osteoarthritis (OA) is the most prevalent musculoskeletal disease, affecting 4% of the Brazilian population. There is important morbidity which progressively leads to chronic use of drugs harmful to this age group, such as anti-inflammatory drugs, increasing the risk of complications and pharmacological interactions. In addition to culminating with disabling functional impairment, osteoarthritis may progress, leading to the need for arthroplasty. Obesity and longevity are important risk factors for osteoarthritis, and both are very prevalent in Brazil. 2010 IBGE census progressions suggest a growing population increase, with 13% of the Brazilian population in 2018. By 2050, 30% of Brazil's population will be over 60 years old. This reflects a gradual increase in the elderly with common morbidities in this age group, such as osteoarthritis. Proper management of OA involves an educational program, multidisciplinary team care, and therapeutic measures aimed at weight loss and maintaining mobility. Insomnia is the most frequent sleep disorder in the elderly and its prevalence almost doubles compared to young adults. In addition to aging, other factors such as the presence of clinical comorbidities, including OA, psychiatric disorders, primary sleep disorders and poor habits (poor sleep hygiene) contribute to this prevalence. During the aging process, in addition to increased nighttime awakenings and increased total waking time at night, there is a reduction in time spent in the deepest stages of sleep, which may be compromised in the presence of pain. Sleep quality is affected by severe fatigue and pain exacerbation in people with OA, ie the sleep approach should always be considered in patients with such comorbidity. In addition to OA, patients with chronic pain usually have insomnia and depression, increasing the use of opioids, sedatives and antidepressants, indicating insomnia and mood changes contributing factors to polypharmacy. A systematic review of chronic OA pain and spinal pain suggests that interventions such as cognitive behavioral therapy and sleep hygiene have good repercussions in people with OA. The study of sleep improvement can facilitate the elderly's quality of life, decrease pain and reduce polypharmacy. This study aims to evaluate the improvement of sleep quality and decrease of daytime sleepiness in elderly with OA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Sleep Disorder
    Keywords
    Osteoarthritis, Quality of Life, Sleep disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    30 Patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy team followed by 7 sessions with the physical educators team (once a week/4 weeks and once every two weeks, three times).
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Should remain under geriatric care after randomization.
    Intervention Type
    Behavioral
    Intervention Name(s)
    PARQVE Program
    Intervention Description
    Two days of lectures about knee OA, come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved, participate in a group therapy session with the psychologists and sessions with the physical educators.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Geriatric Care
    Intervention Description
    Remain under geriatric care as usual
    Primary Outcome Measure Information:
    Title
    Evaluate changes in the quality of sleep after the multiprofessional intervention
    Description
    Answer questionnaires about sleep disorders - Ranges Min: 0 Better - Max: 24 Worse
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change of the insomnia severity index
    Description
    Answer insomnia severity index - Ranges Min: 0 Better - Max: 24 Worse
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change of the Epworth Sleepiness Scale
    Description
    Answer Epworth Sleepiness Scale - Ranges Min: 0 Better - Max: 24 Worse
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change of the subjective complaint of perception of sleep
    Description
    Answer the subjective complaint of perception of sleep - Ranges Min: 0 Better - Max: 24 Worse
    Time Frame
    Baseline, 3 months and 6 months
    Title
    Change in the amount of pain medication
    Description
    Take notes day by day amount of medication
    Time Frame
    Baseline, 3 months and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Classified as Kelgreen and Lawrence grades I to III (K-L), ie any degree of gonarthritis without obliteration of the joint space; Indication of clinical treatment of OA; Patients without moderate to advanced dementia syndrome; Patients without neuropsychiatric diseases whose symptoms may impair the assimilation of the given guidelines. Exclusion Criteria: Missing interventions and not performing the tasks determined by professionals; Patients with low family support; Prescription in the last three months, during the study, some type of hypnotic or sleep inducing medication, which may interfere with the study analysis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Livia Abreu
    Phone
    1126612473
    Email
    murmedicina@outlook.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guilherme Ocampos, MD
    Organizational Affiliation
    University of São Paulo General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23459843
    Citation
    Hawker GA, Badley EM, Borkhoff CM, Croxford R, Davis AM, Dunn S, Gignac MA, Jaglal SB, Kreder HJ, Sale JE. Which patients are most likely to benefit from total joint arthroplasty? Arthritis Rheum. 2013 May;65(5):1243-52. doi: 10.1002/art.37901.
    Results Reference
    background
    PubMed Identifier
    30027075
    Citation
    Ferreira MC, Oliveira JCP, Zidan FF, Franciozi CEDS, Luzo MVM, Abdalla RJ. Total knee and hip arthroplasty: the reality of assistance in Brazilian public health care. Rev Bras Ortop. 2018 Jun 8;53(4):432-440. doi: 10.1016/j.rboe.2018.05.002. eCollection 2018 Jul-Aug.
    Results Reference
    background
    PubMed Identifier
    28642645
    Citation
    Rezende MU, Frucchi R, Pailo AF, Campos GC, Pasqualin T, Hissadomi MI. PARQVE: PROJECT ARTHRITIS RECOVERING QUALITY OF LIFE THROUGH EDUCATION: TWO-YEAR RESULTS. Acta Ortop Bras. 2017 Jan-Feb;25(1):18-24. doi: 10.1590/1413-785220172501165604.
    Results Reference
    background
    PubMed Identifier
    8456235
    Citation
    Bliwise DL. Sleep in normal aging and dementia. Sleep. 1993 Jan;16(1):40-81. doi: 10.1093/sleep/16.1.40. No abstract available.
    Results Reference
    background
    PubMed Identifier
    17452665
    Citation
    Wolkove N, Elkholy O, Baltzan M, Palayew M. Sleep and aging: 1. Sleep disorders commonly found in older people. CMAJ. 2007 Apr 24;176(9):1299-304. doi: 10.1503/cmaj.060792.
    Results Reference
    background
    PubMed Identifier
    30936279
    Citation
    Fu K, Makovey J, Metcalf B, Bennell KL, Zhang Y, Asher R, Robbins SR, Deveza LA, Cistulli PA, Hunter DJ. Sleep Quality and Fatigue Are Associated with Pain Exacerbations of Hip Osteoarthritis: An Internet-based Case-crossover Study. J Rheumatol. 2019 Nov;46(11):1524-1530. doi: 10.3899/jrheum.181406. Epub 2019 Apr 1.
    Results Reference
    background
    PubMed Identifier
    30256279
    Citation
    Liu M, McCurry SM, Belza B, Buchanan DT, Dobra A, Von Korff M, Vitiello MV. Effects of Pain, Insomnia, and Depression on Psychoactive Medication Supply in Older Adults With Osteoarthritis. Med Care. 2018 Dec;56(12):1024-1031. doi: 10.1097/MLR.0000000000000982.
    Results Reference
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    PubMed Identifier
    30342087
    Citation
    Ho KKN, Ferreira PH, Pinheiro MB, Aquino Silva D, Miller CB, Grunstein R, Simic M. Sleep interventions for osteoarthritis and spinal pain: a systematic review and meta-analysis of randomized controlled trials. Osteoarthritis Cartilage. 2019 Feb;27(2):196-218. doi: 10.1016/j.joca.2018.09.014. Epub 2018 Oct 18.
    Results Reference
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