Occupational Therapy Rehabilitation for Frail Elders With Dysphagia

Deglutition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935618
• Other study ID #: H-23026101
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Hvidovre University Hospital
• Contact: Tina Hansen, PhD
• Phone: +45 29243586
• Email: tina.hansen.18[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Oropharyngeal

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Amager and Hvidovre	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SARC-F questionnaire	A screening tool to identify probable sarcopenia. The score range from 0 to 10. A score equal to or greater than 4 is predictive of sarcopenia	At enrollment
Other	Handgrip strength	Continous measures provided with a dynanometer and used as an indicator of signs of sarcopenia	At enrollment
Other	Mid-upper arm circumference (MUAC)	Anthropometric indicator for sarcopenia. Cut-off points of <25 cm (Female) and <31 cm (Male) are used.	At enrollment
Other	The Global Rating of Change scale (GRoC)	A single, self-administered question asking participants to rate how their condition has changed since the start of intervention. The scores range from -3 (labeled "worse") on the left and +3 (labeled "better") on the right, and 0 in the middle (labeled "no change").	End of treatment at 8 weeks
Other	Adverse event	Aspiration pneumonia	End of treatment at 8 weeks
Primary	The McGill Ingestive Skills Assessment-version 2 (MISA2).	Maasure of meal-time task performance. The total score range from 36-108, where higher score indicate higher performance	From enrollment to the end of treatment at 8 weeks
Secondary	Functional Oral Intake Scale (FOIS)	Functional Oral Intake with a score range of 1( no oral intake) to 7 (Total oral diet with no restrictions).	From enrollment to the end of treatment at 8 weeks
Secondary	Nordic Orofacial Test - screening (NOT-S)	Physical examination of orofacial function. The score range from 0 to 6, where higher score indicate impaired function.	From enrollment to the end of treatment at 8 weeks
Secondary	Mini Nutritional Assessment-Short Form	The total score range from 0 to 14, where a score <8 indicates malnutrition, 8-11 indicates risk of malnutrition, and >11 indicates no malnutrition.	From enrollment to the end of treatment at 8 weeks
Secondary	Iowa Oral Performance Instrument (IOPI)	Continuous measure of tongue strength in Kilopascals (KpA).	From enrollment to the end of treatment at 8 weeks
Secondary	Self-reported swallowing difficulties	100 mm VAS scale (left side = no difficulties and right side = unable to swallow).	From enrollment to the end of treatment at 8 weeks
Secondary	Emotional wellbeing and global quality of life	Two single VAS items using a horizontal line from 0 (worst imaginable emotional well-being / worst imaginable quality of life) to 100 mm (perfect emotional wellbeing /perfect quality of life).	At end of treatment at 8 weeks
Secondary	Basic psychological needs in exercise scale (BPNES)	A self-report measure with a total score range of 12 to 60, where higher scores indicate higher levels of autonomy support.	At end of treatment at 8 weeks