PARQUE 70+ Studying Sleep Disorder
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Experimental
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).
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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.
|
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Comparateur actif: Control
Should remain under geriatric care after randomization.
|
Remain under geriatric care as usual
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluate changes in the quality of sleep after the multiprofessional intervention
Délai: 6 months
|
Answer questionnaires about sleep disorders - Ranges Min: 0 Better - Max: 24 Worse
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change of the insomnia severity index
Délai: Baseline, 3 months and 6 months
|
Answer insomnia severity index - Ranges Min: 0 Better - Max: 24 Worse
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Baseline, 3 months and 6 months
|
|
Change of the Epworth Sleepiness Scale
Délai: Baseline, 3 months and 6 months
|
Answer Epworth Sleepiness Scale - Ranges Min: 0 Better - Max: 24 Worse
|
Baseline, 3 months and 6 months
|
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Change of the subjective complaint of perception of sleep
Délai: Baseline, 3 months and 6 months
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Answer the subjective complaint of perception of sleep - Ranges Min: 0 Better - Max: 24 Worse
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Baseline, 3 months and 6 months
|
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Change in the amount of pain medication
Délai: Baseline, 3 months and 6 months
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Take notes day by day amount of medication
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Baseline, 3 months and 6 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Guilherme Ocampos, MD, University of Sao Paulo General Hospital
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Cappesq 04019418.7.0000.0068
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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