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Effect of Supervised in Comparison to Non-supervised Multicomponent Exercise Training on Balance and Quality of Life in Peripheral Diabetic Neuropathy

Effect of Supervised in Comparison to Non-supervised Multicomponent Exercise Training on Balance and Quality of Life in Peripheral Diabetic Neuropathy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06964542
Enrollment
32
Registered
2025-05-09
Start date
2024-09-10
Completion date
2025-05-30
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Diabetic Neuropathy

Keywords

Endurance, Multicomponent exercise training, Diabetes Mellitus, Peripheral Diabetic Neuropathy

Brief summary

THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THIS STUDY IS TO DETERMINE THE effect of supervised in comparison to non-supervised multicomponent exercise training on balance and quality of life in peripheral diabetic neuropathy

Detailed description

Effect of exercises to assess the benefits on strength endurance, balance and mobility. Peripheral Neuropathy aged 55-70 will be recruited in the study. The participants would be assessed through WHOQOL BREF, BERG BALANCE SCALE, TIME UP AND GO TEST . Informed Consent will Be taken after which the participants will be recruited into the two groups, where one group will receive supervised exercise intervention while other group will receive non supervised exercise intervention

Interventions

Patient will be under the complete supervision of physical therapist in a clinical setup.A total of 18 sessions of supervised multicomponent exercise training, thrice a week on alternate days for 6 consecutive weeks, session will be of 45 mins. Multicomponent exercise training including strength and progressive resistance training exercises, actvities will inc. Seated Marching,heel raises,toe raises, sit - to-stand. And balance training activities will involve tandem stands,single leg stance,weight shifting and resistance activities including weight lifting according to feasibility.

PROCEDURENon Supervised

In non supervised group , patient will receive all the intervention with the help of exercise diary and guidance provided by the physical therapist. Patient will perform 18 sessions, thrice a week on alternative days, for 6 consecutive days for 45 mins. In diary patient is provided the tick mark table in which patient will mark the attendance on days ptn will perform the exercise. Diary is a complete guidance for home based exercise program which include QR based videos of performance of all exercises and complete guidelines are provided in urdu for the better understanding along with pictorial information. In this program activities that patient will perform includes; stairs climbing, sit to stand, leg raises, side stepping, leg raises with weight on ankles starting from 1kg to 3kg. Walk starting from 20 minutes to 40 minutes till 6 weeks. Resistance and other activities will be included.

Sponsors

Foundation University Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age 55-70 years (both male and female) * Diagnosed patients of diabetes type 2, 10 years after disease * Completely assessed with Michigan Neuropathy Screening Instrument (MNSI) score scale and patients fulfilling this criterion will be included in this study * Patients who are fulfilling PARQ will be included in study

Exclusion criteria

* Hypoglycemia * Patient having ischemic heart diseases will not be included * unable to walk independent * major orthopedic problems (e.g. lower limb fractures) * Diagnosed neurological and psychological patients

Design outcomes

Primary

MeasureTime frameDescription
Balance4 weeksBerg balance scale. The score range is 0-56, with higher scores indicating better balance and functional mobility.
Strength4 weeksThe MMT scale refers to the Manual Muscle Testing scale, a standardized method used by physical therapists and healthcare providers to assess muscle strength. It has 6 grades.
ENDURANCE4 weeks6-Minute Walk Test (6MWT) ) is a widely used and validated test to assess endurance.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026