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
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Quality of Life, Sleep disorder
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.
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
NCT ID
NCT04059419
First Posted
August 14, 2019
Last Updated
August 19, 2019
Sponsor
University of Sao Paulo General Hospital
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
background
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
background
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