Effect of a Trunk, Hip, Knee and Ankle Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
- Primary Endpoint
- Symptoms
Study Overview
Brief Summary
Diabetic Peripheral Neuropathy (DPN) is one of the most prevalent and debilitating complications of type 2 diabetes mellitus (DM2), especially affecting the distal region of the lower limbs. Such changes affect clinical aspects, such as quality of life. Several pieces of evidence point to therapeutic exercises as an effective way to minimize these deficits. This is a single-blind randomized clinical trial in which participants will be randomly assigned to two groups. The stipulated sample size was 64 participants. The experimental group will receive a distal/proximal exercise program and the control group will receive a distal exercise program available in the literature and previously tested. The intervention will last 12 weeks and will take place twice a week, with an average time of 50 minutes. Neuropathic symptoms will be considered primary outcomes. The secondary outcomes evaluated will be: capillary blood glucose, Mini-BESTest, Falls Efficacy Scale (FES), EQ-5D and HADS (depression and anxiety). This study was approved by the local research ethics committee (Opinion 6.802.243), conducted in accordance with the Declaration of Helsinki and in accordance with the CONSORT guidelines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Blinding will be single-blind, so the outcome evaluator will not be aware of the allocation of participants to the groups.
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult individuals aged between 45 and 75 years, male or female, diagnosed with DM2;
- •DPN diagnosis based on vibration sensitivity tests assessed by a 128 Hz tuning fork and tactile sensitivity measured by a 10 g monofilament
- •Sedentary or irregularly active individuals (level A) according to the Physical Activity Level Classification - IPAQ
- •Score of at least 5 points on the Functional Independence Measure (FIM), i.e., requires supervision, but without physical contact
- •Absence of diabetic foot ulcer (DFU) for at least one month
- •No amputation or at most amputation of fingers, except for the hallux
Exclusion Criteria
- •Individuals involved in physical training programs simultaneously with the intervention
- •History of surgical intervention in the lower limbs or spine
- •Use of walking assistance devices
- •Diagnosis of severe cardiovascular disorder
- •Diagnosis of other neurological impairments in addition to DPN
- •Presence of dementia or inability to provide consistent information
- •Severe retinopathy
Arms & Interventions
Distal protocol
The control group will receive a distal exercise program (ankle and foot) available in the literature and previously tested.
Intervention: Distal protocol (Other)
Proximal/distal protocol
The experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle).
Intervention: Proximal/distal protocol (Other)
Outcomes
Primary Outcomes
Symptoms
Time Frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).
This consists of 15 "yes/no" questions; 13 items assess symptoms of diabetic peripheral neuropathy, one item assesses peripheral vascular disease (item 4), and one item assesses general asthenia (item 10). "Yes" answers to items 1-3, 5-6, 8-9, 11-12, and 14-15 are each awarded one point. A "no" answer to items 7 and 13 is awarded one point.
Secondary Outcomes
- Fear of falling(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
- Anxiety and depression level(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
- Fall risk(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
- Quality of life assessment(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
- Fear of falling(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
- Anxiety and depression level(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
- Fall risk(Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).)
Investigators
Vinicius Saura Cardoso
Principal Investigator
Federal University of Piaui