Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

Официальное название

No Food or Drink Does Any Good Until It is Swallowed: a Proof-of-concept Study on Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

Обзор

The goal of this proof-of-concept study is to assess the potential of a newly developed intervention with combined skill- and strength-based principles for maximizing swallowing-related outcomes and prevent further weakening of the swallowing muscles in older people with dysphagia (difficulty swallowing). The main questions to be answered are: 1. Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia? 2. Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia? 3. Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia? 4. Is there an association between perceived autonomy support and intervention engagement when older individuals with dysphagia receive the intervention during hospitalization and continued in community-based rehabilitation after discharge? Participants will be asked to perform goal-directed and task-specific swallowing exercises in eating and drinking activities where the intensity variables include advancing steps of an altered bolus volume and consistency according to a 17-level task hierarchy, which are introduced according to predetermined progression rules, as well as increases in swallowing repetitions. The dosage is 2-3 individual, face-to-face therapy sessions per week for up to a maximum of eight weeks. A therapy session lasts up to 45 min. In between therapy sessions, participants integrate the achieved level from therapy into their daily meals as self-training.

Вмешательства

• Поведенческое ACT-ING program ( Activity-based skill- and strength training to improve ingestion)
  The intervention is based on a client-centered Occupational therapy task-oriented approach, in which real objects are employed in a realistic context. The intervention uses the effortful swallowing in combination with advancing steps of liquid and food items as resistive forces to challenge the swallow in a safe environment during eating and drinking activities. Progression is realized based on pre-determined progression rules to ensure the right challenges in combination with safety (Hansen et

Первичные конечные точки

• The McGill Ingestive Skills Assessment-version 2 (MISA2). [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (7)

• Functional Oral Intake Scale (FOIS) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Nordic Orofacial Test - screening (NOT-S) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Mini Nutritional Assessment-Short Form [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Iowa Oral Performance Instrument (IOPI) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Self-reported swallowing difficulties [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Emotional wellbeing and global quality of life [Срок оценки: At end of treatment at 8 weeks]
• Basic psychological needs in exercise scale (BPNES) [Срок оценки: At end of treatment at 8 weeks]

Критерии участия

Критерии включения

• A score of 5-18 on the Gugging Swallowing Screen.
• Speaks and understands Danish.
• Are able to cooperate in the intervention and give written informed consent; i.e. is oriented in time, place and own data, and able to perform four simple oral motor movements on request.

• Has given written informed consent.

Критерии исключения

• Esophageal dysphagia.
• Progressive neurologenic dysphagia.
• Psychiatric illness.
• Delirious.
• Infections that requires isolation.
• Need for palliative care.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Copenhagen University Hospital, Amager and Hvidovre — Hvidovre

Публикации

• Hansen T, Laursen LB, Hansen MS. Early Feasibility of an Activity-Based Intervention for Improving Ingestive Functions in Older Adults with Oropharyngeal Dysphagia. Geriatrics (Basel). 2023 Apr 19;8(2):44. doi: 10.3390/geriatrics8020044. PMID 37102970

Идентификаторы

NCT: NCT05935618 · H-23026101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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