Condition category
Digestive System
Date applied
16/04/2019
Date assigned
11/06/2019
Last edited
11/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The tongue plays a crucial role in swallowing. It is the main driving force for pushing the bolus (mixture of food and saliva) from the mouth to the esophagus (food pipe). Decreased tongue strength is shown to contribute significantly to swallowing problems (dysphagia). Dysphagia has a major impact on health care (resulting in pneumonia and the need for feeding tubes) and quality of life. Therefore, the development of successful rehabilitation methods is from major importance. Tongue strength is trainable in a patient-friendly manner, with positive effects from tongue strengthening exercises. A good training program requires an adequate volume of exercise with measurable improvements in combination with a workable degree of effort. Exercise frequency is an important variable of a good training program, since patients and caregivers prefer major improvement with minimized effort. The exercise frequency of most training schemes varies between 3 and 5 times per week. The aim of this study is to compare the gain in tongue strength between training 3 or 5 times per week and to study potential detraining effects 4 and 8 weeks after the training sessions.

Who can participate?
Healthy volunteers without swallowing problems and with a minimum age of 70 years

What does the study involve?
Participants are randomly allocated to tongue strength training either 3 or 5 times per week for 8 weeks. Isolated tongue strength and tongue strength during swallowing are measured at the start of the study, halfway the training program, at the end of the training, and 4 and 8 weeks after finishing the program.

What are the possible benefits and risks of participating?
Benefits from training are an increased functional reserve for tongue strength, observable as increased tongue strength after finishing the protocol. This may avoid/delay the typical symptoms from presbyphagia (swallowing problems in the elderly). There are no risks or side effects of participating in the study.

Where is the study run from?
The study is run from the Antwerp University Hospital, but training sessions are conducted at the patients’ nursing home, supervised by one of the researchers.

When is the study starting and how long is it expected to run for?
September 2015 to June 2016

Who is funding the study?
University Hospital of Antwerp (Belgium)

Who is the main contact?
Mrs Leen Van den Steen
leen.van.den.steen@uza.be

Trial website

Contact information

Type

Public

Primary contact

Mrs Leen Van den Steen

ORCID ID

http://orcid.org/0000-0002-8158-7629

Contact details

Wilrijkstraat 10
Edegem
2650
Belgium
+32 (0)32813441
leen.van.den.steen@uza.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

EFTSE1

Study information

Scientific title

Tongue strengthening exercises in healthy older adults: effect of exercise frequency. A randomized trial

Acronym

EFTSE

Study hypothesis

Training 3x/week results in a higher gain in tongue strength than training 5x/week.

Ethics approval

Approved 14/07/2014, Ethical Committee of the Antwerp University Hospital (Wilrijkstraat 10, 2650 Edegem; Tel: +32 (0)3 821 35 44; Email: ethisch.comité@uza.be), ref: B300201421549

Study design

Interventional single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Tongue strengthening exercise as a form of swallowing rehabilitation

Intervention

Participants were randomly assigned to two different treatment arms. Subjects are assigned to one of the two therapy groups based on a sequence generated by the online randomization tool at www.randomizer.org, following a parallel group design. Clinicians involved in the inclusion procedure are blinded to this assignment by using numbered and sealed envelopes. Per week (7 days), the EX3-group (n=10, 5 males and 5 females) performed 3 sessions of TSE on nonconsecutive days, the EX5-group (n=10, 5 males and 5 females) performed 5 sessions of TSE. Both groups trained for a total of 8 weeks. Training sessions were conducted at the patients’ nursing-home and supervised by one of the researchers. No additional TSE without the researcher present were allowed. Each training session involved 120 tongue-pressure repetitions, 60 anteriorly and 60 posteriorly. TSE were divided into 24 sets of 5 repetitions with 30 seconds rest following each set and with the target level set at 80% of 1RM in order to maintain motivation. A successful repetition was defined as reaching the target level for 3 seconds, using the biofeedback on the LED by the IOPI. A new MIP was determined and correspondent levels of resistance were recalculated every 2 weeks according to the principle of progressive overload.
The Iowa Oral Performance Instrument version 2.3 (IOPI Medical LCC, Redmond, WA USA) was used for MIPA, MIPP, PswalA, and PswalP measurements and for monitoring tongue-palate pressures during training.
MIP and Pswal were measured anteriorly (MIPA, PswalA) and posteriorly (MIPP, PswalP) in both treatment arms. For all strength measurements, the instruction was given to press (MIP) or swallow (Pswal) as hard as possible. The highest pressure obtained over 3 trials for maximum tongue strength was used for MIP and the highest pressure obtained over 3 saliva swallows was used for Pswal. A 3-second time frame per attempt was used to reach maximum values. MIPA, MIPP, PswalA, and PswalP were performed at baseline (BL), after 4 and 8 weeks training (4wT and 8wT) and 4 and 8 weeks after the last training session (4wDT and 8wDT) to document possible detraining effects.

Intervention type

Device

Phase

Phase I

Drug names

Primary outcome measure

Gain in isolated tongue strength represented by MIP (Maximal Isometric Pressure) measured anteriorly (MIPA) and posteriorly (MIPP) in both treatment arms. For all strength measurements, the instruction was given to press (MIP) as hard as possible. The highest pressure obtained over 3 trials for maximum tongue strength was used for MIP. A 3-second time frame per attempt was used to reach maximum values. MIPA and MIPP were performed at baseline (BL), after 4 and 8 weeks training (4wT and 8wT) and 4 and 8 weeks after the last training session (4wDT and 8wDT) to document possible detraining effects. A margin of 48 hours was tolerated for all described time points to accommodate for rescheduling.

Secondary outcome measures

Gain in tongue strength during swallowing represented by Pswal measured anteriorly (PswalA) and posteriorly (PswalP) in both treatment arms. For all strength measurements, the instruction was given to swallow (saliva) as hard as possible. The highest pressure obtained over 3 trials for maximum tongue strength was used for Pswal. A 3-second time frame per attempt was used to reach maximum values. PswalA and PswalP were performed at baseline (BL), after 4 and 8 weeks training (4wT and 8wT) and 4 and 8 weeks after the last training session (4wDT and 8wDT) to document possible detraining effects. A margin of 48 hours was tolerated for all described time points to accommodate for rescheduling.

Overall trial start date

01/09/2015

Overall trial end date

30/06/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Minimum age 70 years
2. Living in nursing home
3. Belgian origin
4. Dutch native speaker
5. MIPP and MIPP within normative data

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Cognitive deficit (MMSE-score > 24)
2. Dysphagia (Yale Swallowing Protocol)

Recruitment start date

01/10/2015

Recruitment end date

01/05/2016

Locations

Countries of recruitment

Belgium

Trial participating centre

Antwerp University Hospital
Wilrijkstraat 10
Edegem
2650
Belgium

Sponsor information

Organisation

University Hospital of Antwerp

Sponsor details

Wilrijkstraat 10
edegem
2650
Belgium
+32 (0)38213441
leen.van.den.steen@uza.be

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Antwerp

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Data are collected and analysed, publication is ready (apart from trial registration).

IPD sharing statement
Participant level data will be held on an external hard disk locked at the University Hospital of Antwerp. Data may be used in future analyses.

Intention to publish date

01/06/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/04/2019: Trial's existence confirmed by ethics committee.