Tongue strengthening exercises in head and neck cancer patients: does level of resistance matter?
| ISRCTN | ISRCTN14447678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14447678 |
| Secondary identifying numbers | NKR_2014_01 |
- Submission date
- 12/02/2015
- Registration date
- 19/02/2015
- Last edited
- 27/10/2020
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Reduced tongue strength (TS) is an important contributing factor to early and late dysphagia (swallowing difficulties) in head and neck cancer (HNC) patients previously treated with chemoradiotherapy (CRT). The evidence is growing that tongue-strengthening exercises (TSE) can improve TS and swallowing function in both healthy and dysphagic subjects. However, little is known about the impact of specific features of an exercise protocol for TS on strength and/or swallowing function). Previous research in sports medicine and physical rehabilitation shows that degree of exercise load is an influential factor for increasing muscle strength in the limb skeletal muscles. Since the tongue is considered a muscular hydrostat (a structure that helps manipulate food), it remains to be proven if the same concepts will apply. This study investigates the effect of 3 TSE protocols with different degrees of exercise load on TS and swallowing.
Who can participate?
Adult head and neck cancer patients previously treated with chemoradiotherapy and suffering from chronic dysphagia.
What does the study involve?
Participants will be randomly assigned to a training schedule of 60, 80, or 100% of their maximal TS respectively. They will be treated during 8 weeks, 3 times a week, executing 120 repetitions of the assigned exercise once per training day. Exercise load is progressively adjusted every two weeks. Patients are evaluated before, during and after treatment by means of TS measurements, fiber optic endoscopic evaluation of swallowing (FEES) and quality of life questionnaires.
What are the possible benefits and risks of participating?
A possible benefit is the increase of tongue strength to some degree, in some participants. There are no risks for patients participating in this study.
Where is the study run from?
Antwerp University Hospital (Belgium)
When is the study starting and how long is it expected to run for?
March 2014 to December 2027
Who is funding the study?
Antwerp University Hospital and Federal Cancer Plan Belgium
Who is the main contact?
Prof Gwen Van Nuffelen
Contact information
Scientific
Wilrijkstraat 10
Edegem (Antwerp)
2650
Belgium
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of intensive tongue strength therapy on anterior and posterior tongue strength, dysphagia and dysphagia related quality of life. |
| Study objectives | 1. Tongue strengthening exercises improve tongue strength in head and neck cancer patients. 2. Tongue strengthening exercises improve functional swallowing in this population. 3. Tongue strengthening exercises improve swallowing related quality of life. 4. The effect of tongue strengthening exercises depend upon the level of resistance. |
| Ethics approval(s) | Ethical Committee of the Antwerp University Hospital and University of Antwerp, Belgium. Chair: Prof. Dr. Patrick Cras. ref 14/24/253, B300201421549 |
| Health condition(s) or problem(s) studied | Patients with dysphagia following head and neck cancer or neurodegenerative diseases. |
| Intervention | At enrollment, 45 head and neck cancer patients, whose dysphagia is primarily related to reduced tongue strength, are randomly assigned to a training schedule of 100% (group 1), 80% (group 2), or 60% (group 3) of their maximal TS respectively. Patients will be treated during 8 weeks, 3 times a week, executing once per training day 120 repetitions of the assigned exercise. Exercise load is progressively adjusted every two weeks. Patients are evaluated before, during and after treatment by means of TS measurements, fiberoptic endoscopic evaluation of swallowing (FEES) and quality of life questionnaires. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Tongue strength measurements: Maximum Isometric Pressures (expressed as kPa) anterior and posterior. The primary measures are evaluated prior to (max 1 week in advance), during (after 4 weeks of therapy), after 8 weeks of therapy and 4 and 8 weeks post treatment. |
| Secondary outcome measures | 1. Swallowing function: the swallowing function will be evaluated using a comprehensive fiber optic endoscopic evaluation of swallowing (FEES) examination, the - Mann Assessment of Swallowing Ability-Cancer (MASA-C), the Functional Oral Intake Scale (FOIS), and a self-evaluation. For the latter a 100 mm visual analogue scale is used with the ends defined as 'I can’t swallow' (0) and 'I don’t have any swallowing difficulties’ (100) respectively. Both the FEES and MASA-C are conducted with 4 different bolus types: 5 and 10 ml of thin liquid, and 5 and 10 ml of yoghurt. Each bolus type is administered 3 times. Outcome measures for FEES are the Penetration-Aspiration-Scale, the Carnaby- Video Fluoroscopic Examination (C-VFE) scales for dysphagia and aspiration, the Pooling-score and the Boston Residue and Clearance Scale (BRACS). 2. Quality of Life: swallowing-related quality of life will be surveyed by means of the Dutch Swallowing Quality-of-Life Questionnaire (DSWAL-QoL) and the Dysphagia Handicap Index. The secondary outcome measures are evaluated prior to (max 1 week in advance), during (after 4 weeks of therapy), after 8 weeks of therapy and 4 and 8 weeks post treatment. |
| Overall study start date | 01/03/2014 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 45 (15 per group) |
| Key inclusion criteria | 1. Head and neck cancer patients previously treated with chemoradiotherapy 2. Men and women older than 18, without cognitive, language, motor, hearing or visual deficits that could interfere with the correct execution of the training. 3. Chronic dysphagia (i.e. present for at least 1 month and no earlier than 6 months after the last day of radiation treatment), primarily related to reduced tongue strength 4. Score 1 or higher for the BRACS-items ‘base of tongue’ and/or ‘valleculae’ at baseline judged by an experienced clinician |
| Key exclusion criteria | 1. History of major oral or head and neck surgery and neurological disorders with an impact on oral function and/or swallowing (amongst others stroke, traumatic brain injury, Parkinson’s disease, Amyotrophic Lateral Sclerosis). 2. Concurrent oral motor exercises or swallowing maneuvers to improve swallowing are not allowed during the study period. |
| Date of first enrolment | 01/05/2014 |
| Date of final enrolment | 01/12/2027 |
Locations
Countries of recruitment
- Belgium
Study participating centre
-
Belgium
Sponsor information
Hospital/treatment centre
Wilrijkstraat 10
Edegem
2650
Belgium
| Phone | +32 (0)3 821 34 41 |
|---|---|
| gwen.van.nuffelen@uza.be | |
"ROR" |
https://ror.org/01hwamj44 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication of the study protocol publication of the data at completion of the study Presentation of the data at at least 2 international conferences including the Dysphagia Research society Meeting |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/09/2015 | Yes | No |
Editorial Notes
27/10/2020: The following changes have been made:
1. The recruitment end date has been changed from 01/11/2016 to 01/12/2027.
2. The overall trial end date has been changed from 31/12/2016 to 31/12/2027 and the plain English summary updated accordingly.
13/06/2016: Publication reference added.
