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Completed

NCT Number: NCT05269758

Feasibility and Impact of Resistance Training for Sarcopenic Dysphagia

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.

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Key information

Conditions

Sarcopenia Atrophy Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Dysphagia related to the esophagus
  • Psychiatric diagnosis
  • Neurodegenerative disease or
  • Needs palliative care
  • Admitted to hospital from a nursing home.

Treatment and study plan

activity-based resistance training of ingestive skills (ACT-ING-program)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Acceptability

    Time frame: Up to 12 weeks

    Semi-structured interviews based on the Theoretical Framework of Acceptability

Secondary outcomes

  1. Emotional wellbeing and global quality of life

    Time frame: Baseline and up to 12 weeks

    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).

  2. Mealtime performance

    Time frame: Baseline and up to 12 weeks

    The McGill Ingestive Skills Assessment-version 2 (MISA2). The total score range from 36-108, where higher score indicate higher performance

  3. Functional oral intake

    Time frame: Baseline and up to 12 weeks

    Functional Oral Intake Scale (FOIS) with a score range of 1( no oral intake) to 7 (Total oral diet with no restrictions).

  4. Nutritional status

    Time frame: Baseline and up to 12 weeks

    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.

  5. Tongue strength and endurance

    Time frame: Baseline and up to 12 weeks

    Iowa Oral Performance Instrument (IOPI).

  6. Intervention progress _ swallow difficulty

    Time frame: During two therapy sessions per week in 12 weeks.

    Self-reported swallowing difficulty of saliva, liquid and food (100 mm VAS scale (left side = no difficulties and right side = unable to swallow).

  7. Intervention progress_ intensity

    Time frame: During two therapy sessions per week in 12 weeks.

    Self-perceived effort from 0 (at rest) to 10 (extremely hard).

  8. Intervention progress _ Swallow ability

    Time frame: During two therapy sessions per week in 12 weeks.

    Records on observed number of successful/unsuccessful swallows.

Other outcomes

  1. Demand for the intervention by the target group

    Time frame: Though study completion, an average of three years.

    Records of recruitment/attrition rates.

  2. Intervention functionality

    Time frame: Though study completion, an average of three years.

    Records of numbers of complete/incomplete therapy sessions.

  3. Intervention adaptations

    Time frame: During two therapy sessions per week in 12 weeks.

    Records on any adaptations (minor or major modifications, addition of new components, or deletions of a component) in the intervention model of the ACT-ING program during therapy. For any adaptations, 'what', 'how' and 'why' are recorded.

  4. Determinants for delivering the ACT-ING program by practitioners

    Time frame: Up to 12 weeks.

    Semi-structured interview based on the Theoretical Domains Framework

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Feasibility and Impact of an Activity-based Intervention for Strengthening Ingestive Functions in Elders With Sarcopenic Dysphagia: a Multiple-case Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2022
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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