Inflammation related miRNAs as an important player between obesity and cancers.
Morteza Gholami, Bagher Larijani, Zhila Zahedi...
https://pubmed.ncbi.nlm.nih.gov/31890692/Actively Recruiting
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-02-04
105
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to evaluate the effectiveness, safety, and adherence to a rehabilitation program using Nordic Walking compared with standard rehabilitation and cardiological counseling in overweight or obese adults with Type II diabetes and cardiovascular complications. Nordic Walking combines special poles with walking to engage about 90% of the bodys muscles and improve cardiovascular performance while reducing joint load. The study is a randomized controlled trial with three parallel groups, focusing on cardiovascular performance and exercise adherence over 6 and 12 months after a 3-month intervention. Participants will be assigned to one of three groups Nordic Walking, Standard Rehabilitation, or Control Group. The Nordic Walking group will attend supervised sessions three times weekly for 12 weeks, each lasting 90 minutes with warm-up, walking, and cool-down phases, progressively increasing intensity. The Standard Rehabilitation group will engage in supervised aerobic exercises five days a week for 40 minutes per session, also gradually increasing intensity. The Control Group receives cardiological counseling with guidance for unsupervised aerobic activity at home. All groups receive a balanced diet plan with moderate caloric restriction based on body composition. During the study, participants will undergo assessments including a Six Minute Walking Test to measure cardiovascular fitness, adherence tracking, evaluations of anxiety, depression, quality of life SF-12, body mass index changes, and peak oxygen uptake. These measures will be taken at intervals up to 12 months. The study monitors safety and dropout rates, aiming to understand the benefits and feasibility of Nordic Walking compared to other rehabilitation methods in this population.
CONDITIONS
EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Patients
N
Nuccia Morici, MD, Ph.D.
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Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants engage in one of three rehabilitation programs: Nordic Walking sessions three times a week for 12 weeks supervised by a Nordic Walking instructor and a cardiologist; Standard Rehabilitation sessions five days a week for 12 weeks supervised by physiotherapists; or receive cardiological counselling with indications for unsupervised aerobic physical activity. All groups receive guidance on a balanced diet with moderate daily caloric restriction based on initial body composition measurements.
3 to 5 visits per week depending on the assigned rehabilitation program
Duration - Up to 12 months
Participants are monitored for outcomes including walking distance, adherence, anxiety, depression, health survey scores, BMI changes, and peak oxygen uptake for up to 12 months following treatment.
Visits scheduled as needed for outcome assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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Lead Sponsor