Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

NCT ID: NCT05935618

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2025-12-31

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.

Conditions

Dysphagia, Oropharyngeal; Deglutition Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined skill- and strength-based swallowing exercise

The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks

Group Type: EXPERIMENTAL

ACT-ING program ( Activity-based skill- and strength training to improve ingestion)

Intervention Type: BEHAVIORAL

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 al, 2023).

Interventions

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 al, 2023).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tina Hansen, PhD, MSc.OT

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tina Hansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Copenhagen University Hospital, Amager and Hvidovre

Hvidovre, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Tina Hansen, PhD

Role: CONTACT

tina.hansen.18@regionh.dk

+45 29243586

Facility Contacts

Tina Hansen, PhD

Role: primary

tina.hansen.18@regionh.dk

+4529243586

References

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.

Reference Type: BACKGROUND

PMID: 37102970 (View on PubMed)

Other Identifiers

H-23026101

Identifier Type: -

Identifier Source: org_study_id