NCT05088993

Brief Summary

Aging can be defined as sequential deterioration that occurs in elderly people including weakness, loss of mobility, decline of physical capabilities, increase susceptibility to disease and many other age-related physiological changes .The beginning of old age in most developed countries is about 60 or 65 years old. Diabetes mellitus (DM) and most commonly type 2 DM is one of the most common chronic non-communicable diseases affecting old people in Saudi Arabia which might be resulted from decline in physical activities. Polyneuropathy (PN) and its serious consequences represent the most common complication in diabetic mellitus which could contribute to an increased gait abnormality and risk of falling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

October 7, 2021

Last Update Submit

October 19, 2021

Conditions

Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (2)

  • Change from baseline spatial and temporal gait parameters at 3 months

    Spatial and temporal gait analysis will be evaluated for every patient at baseline and 3 months post-intervention by using the 3-D motion analysis system.

    Baseline and 3 months post-intervention

  • Change from baseline postural stability at 3 months

    Postural stability assessment by using Balance Biodex stability system measuring (antero-posterior, medio-lateral, and overall stability indices.

    Baseline and 3 months post-intervention

Secondary Outcomes (1)

  • Change from baseline functional capacity at 3 months

    Baseline and 3 months post-intervention

Study Arms (2)

Antigravity Treadmill Group

EXPERIMENTAL

This group received antigravity treadmill training 100% weight bearing and conventional exercise program.

Other: Antigravity treadmill trainingOther: Conventional exercise program

Conventional Exercise Group

ACTIVE COMPARATOR

This group received the conventional exercise program only.

Other: Conventional exercise program

Interventions

Antigravity treadmill trainingOTHER

This group received antigravity treadmill training 100% weight bearing

Antigravity Treadmill Group
Conventional exercise programOTHER

This group received the conventional exercise program only.

Antigravity Treadmill GroupConventional Exercise Group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly Saudi men with diabetic polyneuropathy with history of 2 or more falls within the past 12 months
  • Diagnosed as having uncontrolled Type 2 Diabetes Mellitus, with glycosylated hemoglobin (HbA1c) level between 7 and 11 and fasting glucose level ranged from 7.0 -11.1 mmol/L.
  • Treated only with oral anti-diabetic agents (not taking insulin),
  • Pharmacological treatment had to be stable for at least 3 months before the study.
  • They will be selected among old subjects that were able to walk independently with or without assistive device, but with poor balance

You may not qualify if:

  • Type 1 Diabetes Mellitus,
  • Patients who had got a score over 19 according to Tinetti scale of balance assessment,
  • Patient with malnutrition (BMI \< 21 kg/m2 or with recent weight loss \> 5% body weight in the last month or \> 10% in six months),
  • Patients with established hypertension (resting systolic blood pressure \> 140 mm Hg and diastolic blood pressure \> 90 mm Hg,
  • With any severe chronic or uncontrolled comorbid condition as recent myocardial infarction, unstable angina, acute congestive heart failure, third degree heart block and uncontrolled arrhythmia.
  • Patients will be excluded also if they have abnormal skin integrity e.g. wound or scar tissues or are on other complementary treatment,
  • History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Noor Specialized Hospital

Mecca, 715, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Shamekh M Elshamy, Ph.D.

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 22, 2021

Study Start

February 15, 2021

Primary Completion

June 15, 2021

Study Completion

June 25, 2021

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)