Feasibility and Impact of Resistance Training for Sarcopenic Dysphagia

NCT05269758 | Completed

• 1 other identifier: H-19039031
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Dysphagia; Sarcopenia; Resistance training; Task-oriented; Skill-based

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  Up to 12 weeks

• Acceptability

  Semi-structured interviews based on the Theoretical Framework of Acceptability

  Up to 12 weeks

Secondary Outcomes (8)

• Emotional wellbeing and global quality of life

  Baseline and up to 12 weeks

• Mealtime performance

  Baseline and up to 12 weeks

• Functional oral intake

  Baseline and up to 12 weeks

• Nutritional status

  Baseline and up to 12 weeks

• Tongue strength and endurance

  Baseline and up to 12 weeks

Other Outcomes (4)

• Demand for the intervention by the target group

  Though study completion, an average of three years.

• Intervention functionality

  Though study completion, an average of three years.

• Intervention adaptations

  During two therapy sessions per week in 12 weeks.

Interventions

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 .

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Sarcopenia; Deglutition Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 8, 2022
• Study Start: December 1, 2020
• Primary Completion: January 6, 2023
• Study Completion: February 28, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

DK (1)