NCT05935618 Occupational Therapy Rehabilitation for Frail Elders with Dysphagia
| NCT ID | NCT05935618 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hvidovre University Hospital |
| Condition | Dysphagia, Oropharyngeal |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-07 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-08-07 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Esophageal dysphagia. * Progressive neurologenic dysphagia. * Psychiatric illness. * Delirious. * Infections that requires isolation. * Need for palliative care.
Contact & Investigator
Tina Hansen, PhD
PRINCIPAL INVESTIGATOR
Hvidovre University Hospital
Frequently Asked Questions
Who can join the NCT05935618 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dysphagia, Oropharyngeal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05935618 currently recruiting?
Yes, NCT05935618 is actively recruiting participants. Contact the research team at tina.hansen.18@regionh.dk for enrollment information.
Where is the NCT05935618 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT05935618 clinical trial?
NCT05935618 is sponsored by Hvidovre University Hospital. The principal investigator is Tina Hansen, PhD at Hvidovre University Hospital. The trial plans to enroll 30 participants.