Diabetes Mellitus, Type 2NCT05703152
Effect of a Combined Exercise Program on Neuropathic Pain and Perceived Quality of Life in Type 2 Diabetes
A study testing Combined Exercise in people with Diabetes Mellitus, Type 2 and Neuropathic Pain, run by Maria Gabriela Aké Palomo at 1 site in Mexico.
Trial summary
Therapeutic exercise is one of the therapies used as a treatment for diabetic neuropathy, which is a complication of diabetes. In order to reduce pain and improve the perception of quality of life, a combined therapeutic exercise program will be implemented as an adjuvant and non-pharmacological treatment for diabetic… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Neuropathic Pain, Neuropathy, Diabetic
- What is being tested?
- Combined Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- 31 Oct 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diabetes type 2
- Patients with neuropathy
- Patients with medical treatment
Who cannot join
- Patients with several limit function
- Patients with foot ulcer or amputation
- Patients who are involved in a exercise program already
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad Universitaria de Inserción Social San José Tecoh
Mérida, Yucatán, 97299
About this study
Official title: Effect of a Combined Therapeutic Exercise Program on Neuropathic Pain and Perceived Quality of Life in Patients With Type 2 Diabetes
Therapeutic exercise is one of the therapies used as a treatment for diabetic neuropathy, which is a complication of diabetes. In order to reduce pain and improve the perception of quality of life, a combined therapeutic exercise program will be implemented as an adjuvant and non-pharmacological treatment for diabetic neuropathy.
Read the detailed description
This is a prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest), has been approved by the research and ethics committee of the Faculty of Medicine of the Autonomous University of Yucatan, issuing a report on October 26, 2022. An identification form will be filled out that will include socio-demographic and clinical data: presence of type II diabetes, presence of neuropathy, sex, age, marital status, schooling, occupation, BMI, time of diagnosis, HbA1C, insulin use, medical treatment and a neurological examination of the extremities. The DN4 questionnaire will be used to evaluate neuropathic pain and its characteristics, the VAS will be used to evaluate the degree of intensity or severity of pain, and the SF-36 questionnaire will be used to evaluate perception before and after the combined exercise program. During the intervention stage, a therapeutic exercise program will be applied that will include two modalities: aerobic and resistance exercise in the facilities of the Unidad Universitaria de Inserción social de San José Tecoh. The duration will be 8 weeks with a frequency of 3 sessions per week, with a duration per session of 60 minutes each, to achieve the minimum total time suggested by the guidelines of 150 minutes per week. These exercises will be prescribed in three phases to increase times, series, repetitions and resistances in a progressive manner according to the Borg scale. For the analysis of the variables, the parametric Student's t-test for related samples or the nonparametric Wilcoxon test with significance at 95% reliability will be used. The implementation of the study can demonstrate significant improvements in the symptomatology of diabetic neuropathy, directly impacting on the perception of the quality of life of patients with type II diabetes.
- Being tested
- Combined Exercise
- Keywords
- Diabetes Mellitus type 2, Neuropathic pain, combined exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Neuralgia, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined ExerciseOther
Therapeutic exercise program will be applied that will include two modalities: aerobic and resistance exercise. The duration will be 8 weeks with a frequency of 3 sessions per week, with a duration per session of 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Combined Exercise | Experimental | Therapeutic exercise program Receives: Other: Combined Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in neuropathic pain on Douleur Neuropathique-4 (DN4) at 8 weeks
The DN4 questionnaire will be used to evaluate neuropathic pain and its characteristics. DN4 for neuropathic pain consists of interview questions and physical tests. It has 10 items grouped into four questions: seven items relating to the pain description (burning, painful cold, electric shocks) and to its associated abnormal sensations (tingling, pins and needles, numbness, itching), and the other three items relating to a brief bedside neurological examination in the painful area (touch hypoaesthesia, pinprick hypoaesthesia and tactile dynamic allodynia). For scoring, 1 is given to each positive and 0 to each negative item (total score range 0-10). The cut-off value for diagnosis of neuropathic pain is a total score of 4.
Measured: Baseline and week 8
Change from baseline in pain intensity on Visual Analogue Scale (VAS) at 8 weeks
Pain severity will be assessed using VAS. Each patient will be asked to choose in a perpendicular line on the VAS at the point that signifies the pain severity. The score is ranged 0-10, 0 suggests no pain and 10 suggest severe pain.
Measured: Baseline and week 8
Change from baseline in quality of life on the short form-36 questionnaire (SF-36) at 8 weeks
The 36-item questionnaire consists of eight domains (general health, mental health, role emotion, role physical, body pain, social function, physical function and vitality), which can be further aggregated into a physical component score (PCS) and mental component score (MCS). Total score ranges from 0 to 100, 0 indicates the poor quality of life and 100 indicates the best quality of life.
Measured: Baseline and week 8
Secondary outcomes (5)
Socio-demographic data
An identification form will be filled out at the beginning of the study that will include socio-demographic information: sex (woman/man), age (years), marital status (single/married/widowed/divorced), educational stage (Primary education/High School/University/Master) and occupation (yes/no). All data will be presented in frequency and percentage.
Measured: Before intervention
Clinical data
An identification form will be filled out at the beginning of the study that will include clinical information: presence of type II diabetes, presence of neuropathy, time of diagnosis (years), Glycemic status (A1C percentage), insulin use (yes/no) and medical treatment. All data will be presented in frequency and percentage.
For the neurological examination of the extremities, three instruments will be used: the 10g or Semmes-Weinstein monofilament, 128 hertz tuning fork and Taylor reflex hammer.
Measured: Before intervention
Weight measurement
Body weight will be measured in kilograms (kg) using the body weight scale "Omron HBF-514C".
Measured: Before intervention
Height measurement
Height will be measured in meters (m) using a stadiometer.
Measured: Before intervention
Body Mass Index (BMI) measurement
BMI will be calculated by dividing the weight in kilograms by the height in metres squared (kg/m^2).
Measured: Before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start31 Oct 2022
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Gabriela Aké Palomo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autónoma de Yucatán
- Responsible party
- Sponsor-investigator, Maria Gabriela Aké Palomo, Universidad Autónoma de Yucatán
- Investigators
- Maria Gabriela Aké Palomo, Principal investigator, Facultad de MedicinaDamaris Francis Estrella Castillo, PhD, Study director, Falcultad de MedicinaGloria de los Ángeles Uicab Pool, PhD, Study director, Facultad de EnfermeriaHector Armado Rubio Zapata, Study director, Facultad de Medicina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703152
- Sponsor's protocol ID
- Folio No. 06-2022
- Status last verified
- Nov 2023
- First submitted
- 5 Dec 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
PubMed 27999003Scholz J, Finnerup NB, Attal N, Aziz Q, Baron R, Bennett MI, Benoliel R, Cohen M, Cruccu G, Davis KD, Evers S, First M, Giamberardino MA, Hansson P, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Nurmikko T, Perrot S, Raja SN, Rice ASC, Rowbotham MC, Schug S, Simpson DM, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ, Barke A, Rief W, Treede RD; Classification Committee of the Neuropathic Pain Special Interest Group (NeuPSIG). The IASP classification of chronic pain for ICD-11: chronic neuropathic pain. Pain. 2019 Jan;160(1):53-59. doi: 10.1097/j.pain.0000000000001365.
PubMed 30586071Perez C, Galvez R, Huelbes S, Insausti J, Bouhassira D, Diaz S, Rejas J. Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component. Health Qual Life Outcomes. 2007 Dec 4;5:66. doi: 10.1186/1477-7525-5-66.
PubMed 18053212Pereira EV, Tonin FS, Carneiro J, Pontarolo R, Wiens A. Evaluation of the application of the Diabetes Quality of Life Questionnaire in patients with diabetes mellitus. Arch Endocrinol Metab. 2020 Feb;64(1):59-65. doi: 10.20945/2359-3997000000196. Epub 2020 Mar 13.
PubMed 32187271Kanaley JA, Colberg SR, Corcoran MH, Malin SK, Rodriguez NR, Crespo CJ, Kirwan JP, Zierath JR. Exercise/Physical Activity in Individuals with Type 2 Diabetes: A Consensus Statement from the American College of Sports Medicine. Med Sci Sports Exerc. 2022 Feb 1;54(2):353-368. doi: 10.1249/MSS.0000000000002800.
PubMed 35029593Pan B, Ge L, Xun YQ, Chen YJ, Gao CY, Han X, Zuo LQ, Shan HQ, Yang KH, Ding GW, Tian JH. Exercise training modalities in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis. Int J Behav Nutr Phys Act. 2018 Jul 25;15(1):72. doi: 10.1186/s12966-018-0703-3.
PubMed 30045740
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Combined Therapeutic Exercise Program on Neuropathic Pain and Perceived Quality of Life in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05703152
- Acronym / sponsor ID
- Folio No. 06-2022
- Keywords
- Diabetes Mellitus type 2, Neuropathic pain, combined exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maria Gabriela Aké PalomoUniversity, hospital or other
- Collaborators
- Universidad Autónoma de Yucatán
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Therapeutic exercise is one of the therapies used as a treatment for diabetic neuropathy, which is a complication of diabetes. In order to reduce pain and improve the perception of quality of life, a combined therapeutic exercise program will be implemented as an adjuvant and non-pharmacological treatment for diabetic neuropathy.
Detailed description
This is a prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest), has been approved by the research and ethics committee of the Faculty of Medicine of the Autonomous University of Yucatan, issuing a report on October 26, 2022. An identification form will be filled out that will include socio-demographic and clinical data: presence of type II diabetes, presence of neuropathy, sex, age, marital status, schooling, occupation, BMI, time of diagnosis, HbA1C, insulin use, medical treatment and a neurological examination of the extremities. The DN4 questionnaire will be used to evaluate neuropathic pain and its characteristics, the VAS will be used to evaluate the degree of intensity or severity of pain, and the SF-36 questionnaire will be used to evaluate perception before and after the combined exercise program. During the intervention stage, a therapeutic exercise program will be applied that will include two modalities: aerobic and resistance exercise in the facilities of the Unidad Universitaria de Inserción social de San José Tecoh. The duration will be 8 weeks with a frequency of 3 sessions per week, with a duration per session of 60 minutes each, to achieve the minimum total time suggested by the guidelines of 150 minutes per week. These exercises will be prescribed in three phases to increase times, series, repetitions and resistances in a progressive manner according to the Borg scale. For the analysis of the variables, the parametric Student's t-test for related samples or the nonparametric Wilcoxon test with significance at 95% reliability will be used. The implementation of the study can demonstrate significant improvements in the symptomatology of diabetic neuropathy, directly impacting on the perception of the quality of life of patients with type II diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest)
| Arm | Type | Receives |
|---|---|---|
| Combined Exercise | Experimental | Other: Combined ExerciseTherapeutic exercise program |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with diabetes type 2
- Patients with neuropathy
- Patients with medical treatment
Key exclusion criteria (3 listed)
- Patients with several limit function
- Patients with foot ulcer or amputation
- Patients who are involved in a exercise program already
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined ExerciseTherapeutic exercise program will be applied that will include two modalities: aerobic and resistance exercise. The duration will be 8 weeks with a frequency of 3 sessions per week, with a duration per session of 60 minutes. | Other | Combined Exercise |
Primary outcome
Change from baseline in neuropathic pain on Douleur Neuropathique-4 (DN4) at 8 weeks
Time frame: Baseline and week 8
The DN4 questionnaire will be used to evaluate neuropathic pain and its characteristics. DN4 for neuropathic pain consists of interview questions and physical tests. It has 10 items grouped into four questions: seven items relating to the pain description (burning, painful cold, electric shocks) and to its associated abnormal sensations (tingling, pins and needles, numbness, itching), and the other three items relating to a brief bedside neurological examination in the painful area (touch hypoaesthesia, pinprick hypoaesthesia and tactile dynamic allodynia). For scoring, 1 is given to each positive and 0 to each negative item (total score range 0-10). The cut-off value for diagnosis of neuropathic pain is a total score of 4.
Change from baseline in pain intensity on Visual Analogue Scale (VAS) at 8 weeks
Time frame: Baseline and week 8
Pain severity will be assessed using VAS. Each patient will be asked to choose in a perpendicular line on the VAS at the point that signifies the pain severity. The score is ranged 0-10, 0 suggests no pain and 10 suggest severe pain.
Change from baseline in quality of life on the short form-36 questionnaire (SF-36) at 8 weeks
Time frame: Baseline and week 8
The 36-item questionnaire consists of eight domains (general health, mental health, role emotion, role physical, body pain, social function, physical function and vitality), which can be further aggregated into a physical component score (PCS) and mental component score (MCS). Total score ranges from 0 to 100, 0 indicates the poor quality of life and 100 indicates the best quality of life.
5 secondary outcomes
Socio-demographic data
Time frame: Before intervention
Clinical data
Time frame: Before intervention
Weight measurement
Time frame: Before intervention
Height measurement
Time frame: Before intervention
Body Mass Index (BMI) measurement
Time frame: Before intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Background: PubMed 27999003Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
- Background: PubMed 30586071Scholz J, Finnerup NB, Attal N, Aziz Q, Baron R, Bennett MI, Benoliel R, Cohen M, Cruccu G, Davis KD, Evers S, First M, Giamberardino MA, Hansson P, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Nurmikko T, Perrot S, Raja SN, Rice ASC, Rowbotham MC, Schug S, Simpson DM, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ, Barke A, Rief W, Treede RD; Classification Committee of the Neuropathic Pain Special Interest Group (NeuPSIG). The IASP classification of chronic pain for ICD-11: chronic neuropathic pain. Pain. 2019 Jan;160(1):53-59. doi: 10.1097/j.pain.0000000000001365.
- Background: PubMed 18053212Perez C, Galvez R, Huelbes S, Insausti J, Bouhassira D, Diaz S, Rejas J. Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component. Health Qual Life Outcomes. 2007 Dec 4;5:66. doi: 10.1186/1477-7525-5-66.
- Background: PubMed 32187271Pereira EV, Tonin FS, Carneiro J, Pontarolo R, Wiens A. Evaluation of the application of the Diabetes Quality of Life Questionnaire in patients with diabetes mellitus. Arch Endocrinol Metab. 2020 Feb;64(1):59-65. doi: 10.20945/2359-3997000000196. Epub 2020 Mar 13.
- Background: PubMed 35029593Kanaley JA, Colberg SR, Corcoran MH, Malin SK, Rodriguez NR, Crespo CJ, Kirwan JP, Zierath JR. Exercise/Physical Activity in Individuals with Type 2 Diabetes: A Consensus Statement from the American College of Sports Medicine. Med Sci Sports Exerc. 2022 Feb 1;54(2):353-368. doi: 10.1249/MSS.0000000000002800.
- Results publication: PubMed 30045740Pan B, Ge L, Xun YQ, Chen YJ, Gao CY, Han X, Zuo LQ, Shan HQ, Yang KH, Ding GW, Tian JH. Exercise training modalities in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis. Int J Behav Nutr Phys Act. 2018 Jul 25;15(1):72. doi: 10.1186/s12966-018-0703-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Gabriela Aké Palomo principal investigator
Facultad de Medicina
Damaris Francis Estrella Castillo, PhD study director
Falcultad de Medicina
Gloria de los Ángeles Uicab Pool, PhD study director
Facultad de Enfermeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Exercise in people with Diabetes Mellitus, Type 2 and Neuropathic Pain, run by Maria Gabriela Aké Palomo at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in neuropathic pain on Douleur Neuropathique-4 (DN4) at 8 weeks (time frame: Baseline and week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05703152, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.