Type 2 Diabetes Mellitus and Downhill Aerobic Exercise Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAcibadem University
About this trial
The purpose of this study is to compare the effects of an 8-week supervised downhill walking training program, prescribed based on the 6-minute walk test, on functional capacity, peripheral muscle strength, and cardiovascular responses in individuals with type 2 diabetes mellitus, as compared to a level walking training program.
Participants who agree to take part in the study will be randomly assigned to either the downhill or the level-ground walking group. Both groups will undergo a 6-minute walk test (6MWT) at the beginning of the study, and participants will then undergo an 8-week walking training program-conducted twice a week on a treadmill under the supervision of a physical therapist-in which their walking speed is determined based on their average speed during the 6MWT and gradually increased, with the duration of the sessions also being extended.
Participants will do the following:
* They will participate in walking training sessions at a center twice a week for 8 weeks, under the supervision of a physical therapist. * Once a week for 8 weeks, they will walk the same distance they walked with their supervisor that week as a homework assignment. * They will come to the facility where they conducted their exercise sessions for evaluations at the beginning of the program and after the 8th week.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have been diagnosed with Type 2 diabetes mellitus according to the American Diabetes Association (ADA) diagnostic criteria
Be able to walk independently and be physically capable of walking on a treadmill
Have no acute cardiovascular, neurological, or orthopedic conditions that would prevent participation in the exercise program
No major changes to antidiabetic or cardiometabolic treatments within the last 3 months
Disqualifiers
Patients with severe peripheral neuropathy or a lack of protective sensation
Lower extremity amputation
Diabetic foot ulcer or the presence of severe skin lesions that impair walking
Proliferative diabetic retinopathy or advanced retinopathy that could pose a risk of complications during exercise
Trial design
Design model
Parallel
Treatments tested in this trial
Downhill Aerobic Walking Training
Other interventionThis involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 10-degree downhill, under the supervision of a physical therapist.
Level Aerobic Walking Training
Other interventionThis involves performing a progressive aerobic exercise program-prescribed based on the results of a 6-minute walk test-twice a week for 8 weeks, at a constant 0-degree (i.e., level) slope, under the supervision of a physical therapist.
Home exercise session
Other interventionIt involves assigning the distance walked during that week's exercise session-conducted under the supervision of a physical therapist-as homework to be walked at home on one day of the same week.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Downhill WalkingExperimental treatment 2 interventions
Group B: Level WalkingActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
6-Minute Walk Test (6MWT)
The 6DYT is a walking test used to assess a participant's submaximal exercise capacity, during which the participant walks for six minutes at a self-determined pace. The patient walks as far as possible along a 30-meter corridor for six minutes. The total distance walked during the test will be recorded in meters as the primary outcome measure.
Time frame
From baseline to the end of treatment at 8 weeks2
Measurement of Peripheral Muscle Strength
Muscle strength measurements for hip extension, knee extension, knee flexion, and ankle plantar flexion will be performed using a handheld dynamometer. A dynamometer is a device that enables more quantitative measurements; the person conducting the test holds it in their hand to perform manual muscle testing. Different body segments have different pads. The muscles will be properly positioned and assessed. For each muscle group, measurements will be performed 3 to 5 times on both the right and left extremities, and the peak force will be recorded for each muscle group. Results will be recorded in Newtons.
Time frame
From baseline to the end of treatment at 8 weeks3
Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The RMSSD values will be recorded in milliseconds (ms) as a key indicator of parasympathetic activity.
Time frame
From baseline to the end of treatment at 8 weeks4
Heart Rate Variability (HRV) - Standard Deviation of NN Intervals (SDNN)
Heart Rate Variability (HRV) analysis will be conducted to assess participants' autonomic nervous system responses and cardiovascular adaptability. A high-precision Polar H10 (Polar Electro Oy, Kempele, Finland) heart rate chest strap will be used for data collection. After participants rest for 5 minutes in a supine (on their back) position in a quiet environment, 5-minute short-term R-R interval recordings will be taken. The collected data will be analyzed using the Kubios HRV (v1.7.13, Kubios Oy, Kuopio, Finland) mobile app. The software's automatic artifact correction algorithm will be used to remove signal noise. The SDNN values will be recorded in milliseconds (ms) to reflect overall autonomic variability.
Time frame
From baseline to the end of treatment at 8 weeksSponsors and contacts
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Acibadem University
Lead sponsor
Bezmialem Vakif University
Collaborator
Source ClinicalTrials.gov