Dysphagia, OropharyngealNCT05935618
Occupational Therapy Rehabilitation for Frail Elders with Dysphagia
A study testing ACT-ING program ( Activity-based skill- and strength training to improve ingestion) in people with Dysphagia, Oropharyngeal and Deglutition Disorders, run by Hvidovre University Hospital at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dysphagia, Oropharyngeal, Deglutition Disorders
- What is being tested?
- ACT-ING program ( Activity-based skill- and strength training to improve ingestion)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Esophageal dysphagia.
- Progressive neurologenic dysphagia.
- Psychiatric illness.
- Delirious.
- Infections that requires isolation.
- Need for palliative care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Amager and Hvidovre
Hvidovre, 2650
Tina Hansen, PhD, +4529243586, tina.hansen.18@regionh.dk
About this study
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
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:
Read more
- Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
- Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
- Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
- 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
- Being tested
- ACT-ING program ( Activity-based skill- and strength training to improve ingestion)
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-ING program ( Activity-based skill- and strength training to improve ingestion)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Combined skill- and strength-based swallowing exercise | Experimental | The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks Receives: Behavioral: ACT-ING program ( Activity-based skill- and strength training to improve ingestion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (7)
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).
Measured: From enrollment to the end of treatment at 8 weeks
Nordic Orofacial Test - screening (NOT-S)
Physical examination of orofacial function. The score range from 0 to 6, where higher score indicate impaired function.
Measured: From enrollment to the end of treatment at 8 weeks
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.
Measured: From enrollment to the end of treatment at 8 weeks
Iowa Oral Performance Instrument (IOPI)
Continuous measure of tongue strength in Kilopascals (KpA).
Measured: From enrollment to the end of treatment at 8 weeks
Self-reported swallowing difficulties
100 mm VAS scale (left side = no difficulties and right side = unable to swallow).
Measured: From enrollment to the end of treatment at 8 weeks
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).
Measured: At end of treatment at 8 weeks
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.
Measured: At end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start7 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysphagia, OropharyngealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina Hansen, PhD, MSc.OT, Hvidovre University Hospital
- Investigators
- Tina Hansen, PhD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935618
- Sponsor's protocol ID
- H-23026101
- Status last verified
- Mar 2025
- First submitted
- 29 Jun 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37102970
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05935618
- Acronym / sponsor ID
- H-23026101
- Conditions
- Dysphagia, Oropharyngeal, Deglutition Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
- Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
- Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined skill- and strength-based swallowing exercise | Experimental | Behavioral: ACT-ING program ( Activity-based skill- and strength training to improve ingestion)The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Esophageal dysphagia.
- Progressive neurologenic dysphagia.
- Psychiatric illness.
- Delirious.
- Infections that requires isolation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Combined skill- and strength-based swallowing exercise |
Primary outcome
The McGill Ingestive Skills Assessment-version 2 (MISA2).
Time frame: From enrollment to the end of treatment at 8 weeks
Maasure of meal-time task performance. The total score range from 36-108, where higher score indicate higher performance
7 secondary outcomes
Functional Oral Intake Scale (FOIS)
Time frame: From enrollment to the end of treatment at 8 weeks
Nordic Orofacial Test - screening (NOT-S)
Time frame: From enrollment to the end of treatment at 8 weeks
Mini Nutritional Assessment-Short Form
Time frame: From enrollment to the end of treatment at 8 weeks
Iowa Oral Performance Instrument (IOPI)
Time frame: From enrollment to the end of treatment at 8 weeks
Self-reported swallowing difficulties
Time frame: From enrollment to the end of treatment at 8 weeks
Emotional wellbeing and global quality of life
Time frame: At end of treatment at 8 weeks
Basic psychological needs in exercise scale (BPNES)
Time frame: At end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 37102970Hansen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tina Hansen, PhD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-ING program ( Activity-based skill- and strength training to improve ingestion) in people with Dysphagia, Oropharyngeal and Deglutition Disorders, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tina Hansen, PhD (+45 29243586, tina.hansen.18@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The McGill Ingestive Skills Assessment-version 2 (MISA2). (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.