The impact of exercise frequency from training tongue strength in healthy older adults.
| ISRCTN | ISRCTN13831900 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13831900 |
| Secondary identifying numbers | EFTSE1 |
- Submission date
- 16/04/2019
- Registration date
- 11/06/2019
- Last edited
- 11/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Public
Wilrijkstraat 10
Edegem
2650
Belgium
 ORCID ID |
0000-0002-8158-7629 |
|---|---|
| Phone | +32 (0)32813441 |
| leen.van.den.steen@uza.be |
Study information
| Study design | Interventional single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Tongue strengthening exercises in healthy older adults: effect of exercise frequency. A randomized trial |
| Study acronym | EFTSE |
| Study objectives | Training 3x/week results in a higher gain in tongue strength than training 5x/week. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/09/2015 |
| Completion date | 30/06/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key exclusion criteria | 1. Cognitive deficit (MMSE-score > 24) 2. Dysphagia (Yale Swallowing Protocol) |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 01/05/2016 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Edegem
2650
Belgium
Sponsor information
Hospital/treatment centre
Wilrijkstraat 10
edegem
2650
Belgium
| Phone | +32 (0)38213441 |
|---|---|
| leen.van.den.steen@uza.be | |
"ROR" |
https://ror.org/01hwamj44 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Data are collected and analysed, publication is ready (apart from trial registration). |
| IPD sharing plan | 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. |
Editorial Notes
25/04/2019: Trial's existence confirmed by ethics committee.
