Diabetic Peripheral NeuropathyNCT04807452
Strength And Balance Training on Diabetic Peripheral Neuropathy
A study testing Strength and balance training and Aerobics training in people with Diabetic Peripheral Neuropathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
A Randomized Control Trial was conducted on 20 participants, equally allocated in strength plus balance and aerobic group from February-2020 until December-2020.Participants were selected according to inclusion and exclusion criteria on purposive sampling technique and randomization was done by sealed envelope method. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Strength and balance training and Aerobics training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Mar 2020to 30 Dec 2020
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes (diagnosed by physician)
- Patients with diabetic peripheral neuropathy (diagnosed by Diabetic neuropathy symptom score)
- Age limit 40 to 80 years
- Patients having Toronto neuropathy score 6 or greater
Who cannot join
- Patients having ulceration/infection of feet
- Medical/Surgical conditions limiting functional mobility
- Non-ambulatory patients
- Who are not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Strength And Balance Training on Diabetic Peripheral Neuropathy
A Randomized Control Trial was conducted on 20 participants, equally allocated in strength plus balance and aerobic group from February-2020 until December-2020.Participants were selected according to inclusion and exclusion criteria on purposive sampling technique and randomization was done by sealed envelope method. Inclusion criteria was both gender, 40 years to 80 years, Patients with type 2 diabetes ,diabetic peripheral neuropathy and Toronto neuropathy score 6 or greater. Participants were assessed after taking consent before and after 12 sessions through Toronto clinically neuropathy system, SF-36 and berg balance scale. Data was analyzed using SPSS v.22.
Read the detailed description
Diabetic peripheral neuropathy (DPN) adds to decrease functional performance in people with diabetes. People having DPN found to have decrease proprioception, decrease muscle strength specifically in dorsiflexion and planter-flexors of foot and decrease ankle mobility. An important result of DPN on skeletal muscle is speeded motor axon loss. The injuries to motor units have been found in intrinsic foot and hands muscles as well as dorsiflexion of lower limb. Declined muscle strength with DPN has been told in a number of muscles, counting plantar flexor and dorsi-flexors of ankle, flexor and extensor of knee. As predicted, the peripheral ankle muscles have more decline in strength as compared thigh muscle. M.Davies stated in his study that DPN has a negative effect on the quality of life of an individual.In "Painful diabetic peripheral neuropathy", the emotional and physical of quality of life are markedly changed, and associated anxiety, sleep disturbance and depression are found in 43% of the affected population. Occupation status in 35 to 43% of patients were affected, within job patients, as a result of pain, admit an usual of 5.5 missed workdays/month (30). Besides compromised life quality, patients with DPN also have greater fall risk due to imbalance problem and this risk is probable high in older age, associated depression and severity of DPN. Consequently, falls and broken bones are common among patients affected, occurring in around 25% of adults greater than 65 years with diabetes compared with 18% same population with no diabetes. The most common complication linked with DPN is frequent foot infections, ulcers and amputations, and Charcot's-joints. It was calculated that 15% of diabetic patients will progress to at least one foot ulcer, and one latest study witnessed a yearly occurrence of approximately 2%. It has been stated that 60%-70% of foot ulcers caused by diabetes are neuropathic in nature .Worldwide incidence of foot ulcer is 6.3%, and the occurrence in Africa, North America, Europe, Oceania and Asia was 7.2%, 13.0%, and 5.1%, 3.0% and 5.5% respectively. A literature also described the occurrence of diabetic foot in Pakistan around 7.6%, with more prevalent in men than women. Other difficulties of DPN contains imbalance, greater fall risk, psychosocial problems, mobility restriction, and sever case can lead to amputation thus restricting patient socially and has severely negative effect on patients life.There is very little data available on the effects of DPN on mortality.Elder individuals have a greater frequency of neuropathy than younger people, and are 17 times more likely to fall. It is crucially important to improve strength and in patients having large nerve fiber involvement. Elder can take benefit from intense strength training by improving coordination, increasing muscle strength and balance, and thus dropping fall and fracture risk. Resistance exercise is suggested for patients having diabetes type 2 and controlling mass of skeletal muscle (sarcopenia) with high resistance (1 RM) 2 to 4 days/week. Both side ankle ROM exercise, functional balance exercises like sit to stand, gait training for reduction planter load , Proprioceptive training exercise such as, stepping with alternate feet, balance board training (prevention of fall) .Several studies were also carried on effects of aerobic exercises and reported quit good effects. A literature review was done in the year 2019. Study concluded that among different physical therapy approaches, Aerobic exercise is best for reducing diabetic risk factors including diabetic neuropathy. In the year 2017, S.Billinger conducted a trail on aerobic exercises. Objectives of the study were to find the effects of aerobic exercises on vascular health. Duration of the study was 16 weeks and study reported that there is slight improvement in the vascular health of diabetic patients. Further 2 trails were conducted by S.Dixit in the year 2013 and 2014. Main objective of the study was to evaluate the effects of aerobic exercise on quality of life and progression of diabetic neuropathy respectively. Study stated the positive effects of aerobic training that I could improve the quality of life and slow down the progression of DPN.Another study was done by A.Waje in the year 2020. Study was based on the comparison of balance training exercise with PNF and its effects on balance. Study reported positive effects of both exercises but also report great effects when both treatments were given combined. K.Venkataraman et al conducted a study on short term effects of strength and balance training on functional status and quality of life in patients with diabetic neuropathy. Study claimed that strength and balance training can improve functional status, but failed to report its effects on quality of life and severity of diabetic neuropathy.Different studies were done on effects of PNF on balance and functional status in DPN. A study was done by K.Singh in the year 2016 on the effects of Proprioceptive Neuromuscular Facilitation (PNF) therapy in improving sensorimotor functions. Study claimed that PNF approach can improve the sensorimotor functions of diabetic neuropathic patients .Regarding Proprioceptive treatment, a study was done in the year 2012 by A.El-Wishy. Study was carried out in Egypt on 28 individuals. Purpose of the research was to know and equate the effects of proprioceptive exercises and conventional exercises on balance. Study reported that combination of proprioceptive and conventional exercises were more effective than isolated conventional physical therapy.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Strength and balance training, Aerobics training
- Keywords
- Resistance Training, Diabetic Neuropathies, Quality of Life, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength and balance trainingOther
Passive ROM to possible level of knee (flexion and extension), ankle (dorsiflexion and plantar flexion), forefoot (inversion and eversion) and toe (flexion and extension, adduction and abduction) joints.Resisted flexion and extension of knee, dorsiflexion and planter flexion of ankle, inversion and eversion of foot, flexion/extension, and abduction/adduction of toe with help of thera-band.The exercise prescription for strength training was made at approximately 50% of the estimated 1-RM. Exercise progression was achieved by instructing participants to increase the weight lifted in a specific exercise when they could perform 2 sets of 10-12 repetitions without maximal exertion on 2 consecutive training days. On basis of Borg Rating of Perceived Exertion of 10 to 13.Tandem leg stance for first 2 weeks and then it was progressed to Single leg stance toe and heel stance.For dynamic balance:backward walk Tandem walk and sideways walk.
Aerobics trainingOther
After the baseline assessment, the participant in the Group B received Aerobic exercise with routine medical care.
All patients were followed for 3 days a week for 8 weeks treatment. Control Group received aerobic training. Control group received stretching exercise for 10 minutes and then treadmill walk for 10 minutes and then stationary bicycle for 10 minutes, and steppers for 10 minutes and 5 minute cool down .
| Study group | Role | What they receive |
|---|---|---|
| Strength and balance training | Active comparator | Exercises like ROMS, stretching, static balance and dynamic balance Receives: Other: Strength and balance training |
| Aerobics training | Experimental | Control Group received aerobic training. Receives: Other: Aerobics training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Clinical Neuropathy Scoring System
This tool is used for assessing changes from baseline. This is a quantitative scoring system for evaluating the severity of peripheral neuropathy primarily for the feet. Total score ranges from normal=0 to maximum= 19.
Interpretation:
- No neuropathy 0-5 points
- Mild neuropathy 6-8 points
- Moderate neuropathy 9-11 points
- Severe neuropathy 12+ points Toronto Clinical Neuropathy Scoring System has good inter-class reliability (Cronbach's alpha 0.86). It is a valid instrument to reflect the presence and severity of DSP as measured by sural nerve morphology and electrophysiology findings, and morphological changes in DSP. This evidence suggests that the Toronto CSS may prove useful in documenting and monitoring DSP in the clinic and in clinical research trials.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start30 Mar 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807452
- Sponsor's protocol ID
- REC/00667 Farhan Haleem
- Status last verified
- Mar 2021
- First submitted
- 21 Dec 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang XF, Tan BK. Effects of an ethanolic extract of Gynura procumbens on serum glucose, cholesterol and triglyceride levels in normal and streptozotocin-induced diabetic rats. Singapore Med J. 2000 Jan;41(1):9-13.
PubMed 10783673Venkataraman K, Tai BC, Khoo EYH, Tavintharan S, Chandran K, Hwang SW, Phua MSLA, Wee HL, Koh GCH, Tai ES. Short-term strength and balance training does not improve quality of life but improves functional status in individuals with diabetic peripheral neuropathy: a randomised controlled trial. Diabetologia. 2019 Dec;62(12):2200-2210. doi: 10.1007/s00125-019-04979-7. Epub 2019 Aug 29.
PubMed 31468106Davies M, Brophy S, Williams R, Taylor A. The prevalence, severity, and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care. 2006 Jul;29(7):1518-22. doi: 10.2337/dc05-2228.
PubMed 16801572Donoghue D; Physiotherapy Research and Older People (PROP) group; Stokes EK. How much change is true change? The minimum detectable change of the Berg Balance Scale in elderly people. J Rehabil Med. 2009 Apr;41(5):343-6. doi: 10.2340/16501977-0337.
PubMed 19363567Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
PubMed 1468055Rojhani-Shirazi Z, Barzintaj F, Salimifard MR. Comparison the effects of two types of therapeutic exercises Frenkele vs. Swiss ball on the clinical balance measures in patients with type II diabetic neuropathy. Diabetes Metab Syndr. 2017 Nov;11 Suppl 1:S29-S32. doi: 10.1016/j.dsx.2016.08.020. Epub 2016 Sep 15.
PubMed 27720359Dixit S, Maiya AG, Shastry BA. Effect of aerobic exercise on peripheral nerve functions of population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, parallel group randomized controlled trial. J Diabetes Complications. 2014 May-Jun;28(3):332-9. doi: 10.1016/j.jdiacomp.2013.12.006. Epub 2013 Dec 27.
PubMed 24507164Billinger SA, Sisante JV, Alqahtani AS, Pasnoor M, Kluding PM. Aerobic exercise improves measures of vascular health in diabetic peripheral neuropathy. Int J Neurosci. 2017 Jan;127(1):80-85. doi: 10.3109/00207454.2016.1144056. Epub 2016 Feb 16.
PubMed 26785723Yaribeygi H, Butler AE, Sahebkar A. Aerobic exercise can modulate the underlying mechanisms involved in the development of diabetic complications. J Cell Physiol. 2019 Aug;234(8):12508-12515. doi: 10.1002/jcp.28110. Epub 2019 Jan 8.
PubMed 30623433Nomura T, Kawae T, Kataoka H, Ikeda Y. Assessment of lower extremity muscle mass, muscle strength, and exercise therapy in elderly patients with diabetes mellitus. Environ Health Prev Med. 2018 May 17;23(1):20. doi: 10.1186/s12199-018-0710-7.
PubMed 29776338
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strength And Balance Training on Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04807452
- Acronym / sponsor ID
- REC/00667 Farhan Haleem
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Resistance Training, Diabetic Neuropathies, Quality of Life, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 19 Mar 2021 (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.
A Randomized Control Trial was conducted on 20 participants, equally allocated in strength plus balance and aerobic group from February-2020 until December-2020.Participants were selected according to inclusion and exclusion criteria on purposive sampling technique and randomization was done by sealed envelope method. Inclusion criteria was both gender, 40 years to 80 years, Patients with type 2 diabetes ,diabetic peripheral neuropathy and Toronto neuropathy score 6 or greater. Participants were assessed after taking consent before and after 12 sessions through Toronto clinically neuropathy system, SF-36 and berg balance scale. Data was analyzed using SPSS v.22.
Detailed description
Diabetic peripheral neuropathy (DPN) adds to decrease functional performance in people with diabetes. People having DPN found to have decrease proprioception, decrease muscle strength specifically in dorsiflexion and planter-flexors of foot and decrease ankle mobility. An important result of DPN on skeletal muscle is speeded motor axon loss. The injuries to motor units have been found in intrinsic foot and hands muscles as well as dorsiflexion of lower limb. Declined muscle strength with DPN has been told in a number of muscles, counting plantar flexor and dorsi-flexors of ankle, flexor and extensor of knee. As predicted, the peripheral ankle muscles have more decline in strength as compared thigh muscle. M.Davies stated in his study that DPN has a negative effect on the quality of life of an individual.In "Painful diabetic peripheral neuropathy", the emotional and physical of quality of life are markedly changed, and associated anxiety, sleep disturbance and depression are found in 43% of the affected population. Occupation status in 35 to 43% of patients were affected, within job patients, as a result of pain, admit an usual of 5.5 missed workdays/month (30). Besides compromised life quality, patients with DPN also have greater fall risk due to imbalance problem and this risk is probable high in older age, associated depression and severity of DPN. Consequently, falls and broken bones are common among patients affected, occurring in around 25% of adults greater than 65 years with diabetes compared with 18% same population with no diabetes. The most common complication linked with DPN is frequent foot infections, ulcers and amputations, and Charcot's-joints. It was calculated that 15% of diabetic patients will progress to at least one foot ulcer, and one latest study witnessed a yearly occurrence of approximately 2%. It has been stated that 60%-70% of foot ulcers caused by diabetes are neuropathic in nature .Worldwide incidence of foot ulcer is 6.3%, and the occurrence in Africa, North America, Europe, Oceania and Asia was 7.2%, 13.0%, and 5.1%, 3.0% and 5.5% respectively. A literature also described the occurrence of diabetic foot in Pakistan around 7.6%, with more prevalent in men than women. Other difficulties of DPN contains imbalance, greater fall risk, psychosocial problems, mobility restriction, and sever case can lead to amputation thus restricting patient socially and has severely negative effect on patients life.There is very little data available on the effects of DPN on mortality.Elder individuals have a greater frequency of neuropathy than younger people, and are 17 times more likely to fall. It is crucially important to improve strength and in patients having large nerve fiber involvement. Elder can take benefit from intense strength training by improving coordination, increasing muscle strength and balance, and thus dropping fall and fracture risk. Resistance exercise is suggested for patients having diabetes type 2 and controlling mass of skeletal muscle (sarcopenia) with high resistance (1 RM) 2 to 4 days/week. Both side ankle ROM exercise, functional balance exercises like sit to stand, gait training for reduction planter load , Proprioceptive training exercise such as, stepping with alternate feet, balance board training (prevention of fall) .Several studies were also carried on effects of aerobic exercises and reported quit good effects. A literature review was done in the year 2019. Study concluded that among different physical therapy approaches, Aerobic exercise is best for reducing diabetic risk factors including diabetic neuropathy. In the year 2017, S.Billinger conducted a trail on aerobic exercises. Objectives of the study were to find the effects of aerobic exercises on vascular health. Duration of the study was 16 weeks and study reported that there is slight improvement in the vascular health of diabetic patients. Further 2 trails were conducted by S.Dixit in the year 2013 and 2014. Main objective of the study was to evaluate the effects of aerobic exercise on quality of life and progression of diabetic neuropathy respectively. Study stated the positive effects of aerobic training that I could improve the quality of life and slow down the progression of DPN.Another study was done by A.Waje in the year 2020. Study was based on the comparison of balance training exercise with PNF and its effects on balance. Study reported positive effects of both exercises but also report great effects when both treatments were given combined. K.Venkataraman et al conducted a study on short term effects of strength and balance training on functional status and quality of life in patients with diabetic neuropathy. Study claimed that strength and balance training can improve functional status, but failed to report its effects on quality of life and severity of diabetic neuropathy.Different studies were done on effects of PNF on balance and functional status in DPN. A study was done by K.Singh in the year 2016 on the effects of Proprioceptive Neuromuscular Facilitation (PNF) therapy in improving sensorimotor functions. Study claimed that PNF approach can improve the sensorimotor functions of diabetic neuropathic patients .Regarding Proprioceptive treatment, a study was done in the year 2012 by A.El-Wishy. Study was carried out in Egypt on 28 individuals. Purpose of the research was to know and equate the effects of proprioceptive exercises and conventional exercises on balance. Study reported that combination of proprioceptive and conventional exercises were more effective than isolated conventional physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength and balance training | Active comparator | Other: Strength and balance trainingExercises like ROMS, stretching, static balance and dynamic balance |
| Aerobics training | Experimental | Other: Aerobics trainingControl Group received aerobic training. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with type 2 diabetes (diagnosed by physician)
- Patients with diabetic peripheral neuropathy (diagnosed by Diabetic neuropathy symptom score)
- Age limit 40 to 80 years
- Patients having Toronto neuropathy score 6 or greater
Key exclusion criteria (4 listed)
- Patients having ulceration/infection of feet
- Medical/Surgical conditions limiting functional mobility
- Non-ambulatory patients
- Who are not willing to participate
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 |
|---|---|---|
| Strength and balance trainingPassive ROM to possible level of knee (flexion and extension), ankle (dorsiflexion and plantar flexion), forefoot (inversion and eversion) and toe (flexion and extension, adduction and abduction) joints.Resisted flexion and extension of knee, dorsiflexion and planter flexion of ankle, inversion and eversion of foot, flexion/extension, and abduction/adduction of toe with help of thera-band.The exercise prescription for strength training was made at approximately 50% of the estimated 1-RM. Exercise progression was achieved by instructing participants to increase the weight lifted in a specific exercise when they could perform 2 sets of 10-12 repetitions without maximal exertion on 2 consecutive training days. On basis of Borg Rating of Perceived Exertion of 10 to 13.Tandem leg stance for first 2 weeks and then it was progressed to Single leg stance toe and heel stance.For dynamic balance:backward walk Tandem walk and sideways walk. | Other | Strength and balance training |
| Aerobics trainingAfter the baseline assessment, the participant in the Group B received Aerobic exercise with routine medical care. All patients were followed for 3 days a week for 8 weeks treatment. Control Group received aerobic training. Control group received stretching exercise for 10 minutes and then treadmill walk for 10 minutes and then stationary bicycle for 10 minutes, and steppers for 10 minutes and 5 minute cool down . | Other | Aerobics training |
Primary outcome
Toronto Clinical Neuropathy Scoring System
Time frame: 4th week
This tool is used for assessing changes from baseline. This is a quantitative scoring system for evaluating the severity of peripheral neuropathy primarily for the feet. Total score ranges from normal=0 to maximum= 19. Interpretation: * No neuropathy 0-5 points * Mild neuropathy 6-8 points * Moderate neuropathy 9-11 points * Severe neuropathy 12+ points Toronto Clinical Neuropathy Scoring System has good inter-class reliability (Cronbach's alpha 0.86). It is a valid instrument to reflect the presence and severity of DSP as measured by sural nerve morphology and electrophysiology findings, and morphological changes in DSP. This evidence suggests that the Toronto CSS may prove useful in documenting and monitoring DSP in the clinic and in clinical research trials.
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 19 Mar 2021.
- Background: PubMed 10783673Zhang XF, Tan BK. Effects of an ethanolic extract of Gynura procumbens on serum glucose, cholesterol and triglyceride levels in normal and streptozotocin-induced diabetic rats. Singapore Med J. 2000 Jan;41(1):9-13.
- Background: PubMed 31468106Venkataraman K, Tai BC, Khoo EYH, Tavintharan S, Chandran K, Hwang SW, Phua MSLA, Wee HL, Koh GCH, Tai ES. Short-term strength and balance training does not improve quality of life but improves functional status in individuals with diabetic peripheral neuropathy: a randomised controlled trial. Diabetologia. 2019 Dec;62(12):2200-2210. doi: 10.1007/s00125-019-04979-7. Epub 2019 Aug 29.
- Background: PubMed 16801572Davies M, Brophy S, Williams R, Taylor A. The prevalence, severity, and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care. 2006 Jul;29(7):1518-22. doi: 10.2337/dc05-2228.
- Background: PubMed 19363567Donoghue D; Physiotherapy Research and Older People (PROP) group; Stokes EK. How much change is true change? The minimum detectable change of the Berg Balance Scale in elderly people. J Rehabil Med. 2009 Apr;41(5):343-6. doi: 10.2340/16501977-0337.
- Background: PubMed 1468055Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
- Background: PubMed 27720359Rojhani-Shirazi Z, Barzintaj F, Salimifard MR. Comparison the effects of two types of therapeutic exercises Frenkele vs. Swiss ball on the clinical balance measures in patients with type II diabetic neuropathy. Diabetes Metab Syndr. 2017 Nov;11 Suppl 1:S29-S32. doi: 10.1016/j.dsx.2016.08.020. Epub 2016 Sep 15.
- Background: PubMed 24507164Dixit S, Maiya AG, Shastry BA. Effect of aerobic exercise on peripheral nerve functions of population with diabetic peripheral neuropathy in type 2 diabetes: a single blind, parallel group randomized controlled trial. J Diabetes Complications. 2014 May-Jun;28(3):332-9. doi: 10.1016/j.jdiacomp.2013.12.006. Epub 2013 Dec 27.
- Background: PubMed 26785723Billinger SA, Sisante JV, Alqahtani AS, Pasnoor M, Kluding PM. Aerobic exercise improves measures of vascular health in diabetic peripheral neuropathy. Int J Neurosci. 2017 Jan;127(1):80-85. doi: 10.3109/00207454.2016.1144056. Epub 2016 Feb 16.
- Background: PubMed 30623433Yaribeygi H, Butler AE, Sahebkar A. Aerobic exercise can modulate the underlying mechanisms involved in the development of diabetic complications. J Cell Physiol. 2019 Aug;234(8):12508-12515. doi: 10.1002/jcp.28110. Epub 2019 Jan 8.
- Background: PubMed 29776338Nomura T, Kawae T, Kataoka H, Ikeda Y. Assessment of lower extremity muscle mass, muscle strength, and exercise therapy in elderly patients with diabetes mellitus. Environ Health Prev Med. 2018 May 17;23(1):20. doi: 10.1186/s12199-018-0710-7.
- Individual participant dataSharing planned: No
Related trials for Diabetic Peripheral Neuropathy
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
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.
Aruba Saeed, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength and balance training and Aerobics training in people with Diabetic Peripheral Neuropathy, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 4 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 19 Mar 2021. 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 Pakistan. 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?
Toronto Clinical Neuropathy Scoring System (time frame: 4th week). 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 NCT04807452, which also lists 10 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 19 Mar 2021.