SarcopeniaNCT05269758
Feasibility and Impact of Resistance Training for Sarcopenic Dysphagia
An observational study of Sarcopenia and Dysphagia, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to test and optimize the feasibility of an activity-based resistance training program for patients with sarcopenic dysphagia. The study is a feasibility study designed as a multiple-case study with quantitative and qualitative data sources related to a number of feasibility outcomes and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Dysphagia
- What is being tested?
- activity-based resistance training of ingestive skills (ACT-ING-program)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2020to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants admitted to an acute hospital for medical reasons (endocrinology, pulmonary medicine, infectious medicine, gastrology), and referred for dysphagia assessment by an Occupational Therapist .
Who may be able to join
- Speaks and understand Danish language, and able to provide written informed consent for participation
- Dysphagia verified by a Gugging Swallowing Screen
- Generalized sarcopenia determined by a Danish version of the questionnaire SARC-F
- Sarcopenia of the swallowing mechanism indicated by reduced tongue strength measured with the Iowa Oral Performance Instrument
Who cannot join
- Dysphagia related to the esophagus
- Psychiatric diagnosis
- Neurodegenerative disease or
- Needs palliative care
- Admitted to hospital from a nursing home.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Impact of an Activity-based Intervention for Strengthening Ingestive Functions in Elders With Sarcopenic Dysphagia: a Multiple-case Study
The purpose of the study is to test and optimize the feasibility of an activity-based resistance training program for patients with sarcopenic dysphagia. The study is a feasibility study designed as a multiple-case study with quantitative and qualitative data sources related to a number of feasibility outcomes and clinical outcomes during and after the intervention. Participants are 15 patients> 65 years of age are referred for dysphagia assessment by an Occupational Therapist (patients may be admitted to several different wards (endocrinology, pulmonary medicine, infectious medicine, gastrology). The intervention is offered during hospitalization and after discharge for a maximum of 12 weeks.
- Conditions
- Sarcopenia, Dysphagia
- Being tested
- activity-based resistance training of ingestive skills (ACT-ING-program)
- Keywords
- Dysphagia, Sarcopenia, Resistance training, Task-oriented, Skill-based
- Medical subject headings
- Sarcopenia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activity-based resistance training of ingestive skills (ACT-ING-program)Behavioural
The ACT-ING program is based on a task-oriented approach within motor behavior theories and combines resistance training principles with goal-directed and task-specific swallowing exercises in eating and drinking activities through a client-centered procedure informed by self-determination theory.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention tolerance
Time-series of participants rated level of concern for aspiration on a 100 mm VAS-scale ((left side = no concerns and right side = maximal concerns). The success criterion is that 80% of the VAS scales are in the area of 'no concerns' for aspiration.
Measured: During two therapy sessions per week in 12 weeks
Adverse effects
Any expected and unintended events during the therapy sessions and the self-training are recorded.
Measured: During two therapy sessions per week in 12 weeks
Intervention usefulness
Participant self-report on the subscale 'Value/usefulness' from the Intrinsic Motivation Inventory (IMI). The subscale covers 7 items to be rated on a 7-point Likert scale (1=Not at all true to 7=very true). A high score indicate high usability.
Measured: Up to 12 weeks
Acceptability
Semi-structured interviews based on the Theoretical Framework of Acceptability
Measured: Up to 12 weeks
Secondary outcomes (8)
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: Baseline and up to 12 weeks
Mealtime performance
The McGill Ingestive Skills Assessment-version 2 (MISA2). The total score range from 36-108, where higher score indicate higher performance
Measured: Baseline and up to 12 weeks
Functional oral intake
Functional Oral Intake Scale (FOIS) with a score range of 1( no oral intake) to 7 (Total oral diet with no restrictions).
Measured: Baseline and up to 12 weeks
Nutritional status
The modified Mini Nutritional Assessment Scale-Short Form (MNA-SF). 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: Baseline and up to 12 weeks
Tongue strength and endurance
Iowa Oral Performance Instrument (IOPI).
Measured: Baseline and up to 12 weeks
Intervention progress _ swallow difficulty
Self-reported swallowing difficulty of saliva, liquid and food (100 mm VAS scale (left side = no difficulties and right side = unable to swallow).
Measured: During two therapy sessions per week in 12 weeks.
Intervention progress_ intensity
Self-perceived effort from 0 (at rest) to 10 (extremely hard).
Measured: During two therapy sessions per week in 12 weeks.
Intervention progress _ Swallow ability
Records on observed number of successful/unsuccessful swallows.
Measured: During two therapy sessions per week in 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Dec 2020
- Primary completion6 Jan 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269758
- Sponsor's protocol ID
- H-19039031
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of an Activity-based Intervention for Strengthening Ingestive Functions in Elders With Sarcopenic Dysphagia: a Multiple-case Study
- ClinicalTrials.gov ID
- NCT05269758
- Acronym / sponsor ID
- H-19039031
- Conditions
- Sarcopenia, Dysphagia
- Keywords
- Dysphagia, Sarcopenia, Resistance training, Task-oriented, Skill-based
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 8 Mar 2022 (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 purpose of the study is to test and optimize the feasibility of an activity-based resistance training program for patients with sarcopenic dysphagia. The study is a feasibility study designed as a multiple-case study with quantitative and qualitative data sources related to a number of feasibility outcomes and clinical outcomes during and after the intervention. Participants are 15 patients> 65 years of age are referred for dysphagia assessment by an Occupational Therapist (patients may be admitted to several different wards (endocrinology, pulmonary medicine, infectious medicine, gastrology). The intervention is offered during hospitalization and after discharge for a maximum of 12 weeks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Participants admitted to an acute hospital for medical reasons (endocrinology, pulmonary medicine, infectious medicine, gastrology), and referred for dysphagia assessment by an Occupational Therapist .
Key inclusion criteria (4 listed)
- Speaks and understand Danish language, and able to provide written informed consent for participation
- Dysphagia verified by a Gugging Swallowing Screen
- Generalized sarcopenia determined by a Danish version of the questionnaire SARC-F
- Sarcopenia of the swallowing mechanism indicated by reduced tongue strength measured with the Iowa Oral Performance Instrument
Key exclusion criteria (5 listed)
- Dysphagia related to the esophagus
- Psychiatric diagnosis
- Neurodegenerative disease or
- Needs palliative care
- Admitted to hospital from a nursing home.
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 |
|---|---|---|
| activity-based resistance training of ingestive skills (ACT-ING-program)The ACT-ING program is based on a task-oriented approach within motor behavior theories and combines resistance training principles with goal-directed and task-specific swallowing exercises in eating and drinking activities through a client-centered procedure informed by self-determination theory. | Behavioural | – |
Primary outcome
Intervention tolerance
Time frame: During two therapy sessions per week in 12 weeks
Time-series of participants rated level of concern for aspiration on a 100 mm VAS-scale ((left side = no concerns and right side = maximal concerns). The success criterion is that 80% of the VAS scales are in the area of 'no concerns' for aspiration.
Adverse effects
Time frame: During two therapy sessions per week in 12 weeks
Any expected and unintended events during the therapy sessions and the self-training are recorded.
Intervention usefulness
Time frame: Up to 12 weeks
Participant self-report on the subscale 'Value/usefulness' from the Intrinsic Motivation Inventory (IMI). The subscale covers 7 items to be rated on a 7-point Likert scale (1=Not at all true to 7=very true). A high score indicate high usability.
Acceptability
Time frame: Up to 12 weeks
Semi-structured interviews based on the Theoretical Framework of Acceptability
8 secondary outcomes
Emotional wellbeing and global quality of life
Time frame: Baseline and up to 12 weeks
Mealtime performance
Time frame: Baseline and up to 12 weeks
Functional oral intake
Time frame: Baseline and up to 12 weeks
Nutritional status
Time frame: Baseline and up to 12 weeks
Tongue strength and endurance
Time frame: Baseline and up to 12 weeks
Intervention progress _ swallow difficulty
Time frame: During two therapy sessions per week in 12 weeks.
Intervention progress_ intensity
Time frame: During two therapy sessions per week in 12 weeks.
Intervention progress _ Swallow ability
Time frame: During two therapy sessions per week in 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Dysphagia, 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 5 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: finished, as of the sponsor's last update on 2 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention tolerance (time frame: During two therapy sessions per week in 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2023.