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NCT06309654Completed

Home-Based Circuit Training in Overweight/Obese Older Adult Patients With Knee Osteoarthritis and Type 2 Diabetes

Home-Based Circuit Training Attenuates Cardiovascular Risk and Amplifies Functionality and Quality of Life in Overweight/Obese Older Adult Patients With KOA and Type 2 Diabetes: A Randomized Controlled Trial During the COVID-19

Source: ClinicalTrials.gov · Last updated 13 Mar 2024

Brief summary (registry, in English)

Background: Obesity and type 2 diabetes mellitus (T2DM) are considered two of the most prevalent metabolic diseases linked to the onset of knee pain caused by osteoarthritis. Regular exercise has been documented as a principal component of a prevention, management, and treatment strategy for knee osteoarthritis (KOA) patients. However, evidence-based exercise protocols for individuals with comorbidities such as obesity, T2DM, and KOA are scarce. Thus, the present pragmatic randomized controlled trial aimed to investigate the effectiveness of a 12-week home-based circuit training (HBCT) protocol on various indicators related to KOA and cardiometabolic health among overweight/obese older adult patients with KOA and T2DM during the COVID-19 lockdown. Methods: Seventy overweight or obese patients with KOA and T2DM (62.2 ± 6.1 years; 56% female) were randomly assigned to the intervention group (n = 35, HBCT) or the no-exercise control group (n = 35, CON). HBCT performed a progressive protocol (seven exercises; 15-30 repetitions per exercise, 1 min passive rest between exercises; 2-4 rounds per session; 20-60 min total session duration). The knee injury and osteoarthritis symptoms, cardiovascular and metabolic risk factors, cardiorespiratory fitness, and renal function were assessed at baseline and following the 12-week intervention. Results: HBCT significantly improved HBCT improved the vast majority of outcomes related to cardiometabolic health and knee osteoarthritis symptoms compared to CON (p\<0.05). No significant differences were detected in total bilirubin, sodium, urea, resting heart rate, or KOOS-sport between HBCT and CON. Conclusion: These findings suggest that an injury-free HBCT program may improve several cardiometabolic health- and KOA-related indices in overweight/obese patients with T2DM and KOA. Such results may encourage clinicians and practitioners to adopt real-world exercise training approaches when prescribing physical exercise to patients characterized by impaired metabolic and musculoskeletal health.

Status (registry)
Completed
Study type
Interventional
Enrollment
70 (actual)
First submitted
1 Mar 2024
Start date
Sept 2021
Primary completion date
Sept 2023
Lead sponsor
Princess Nourah Bint Abdulrahman University
NCT number
NCT06309654

What you commit to

  • Study type: Interventional
  • Participants enrolled: 70
  • From Sept 2021 to the primary completion date, Sept 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • changes in medication, supplementation, and/or diet

Other illness

  • dementia or any psychiatric diseases
  • tested positive for COVID-19

Other

  • secondary KOA
  • acute knee pain,
  • changes in habitual physical activity
  • smoking
  • adherence to less than 90% of total prescribed exercise sessions

Who the study is looking for

  • age \>55 years
  • diagnosed with KOA with Kellgren-Lawrence criteria grades 2 and 3, indicating moderate KOA, which was based on radiological assessments conducted by a traumatologist
  • chronic knee pain for more than three months
  • T2DM based on fasting plasma glucose \>7.0 mmol·L-1 and glycated hemoglobin (HbA1c) \>6.5%,
  • overweight or obesity (BMI ≥25 kg/m2)
  • providing a certificate of a negative COVID-19 diagnostic test (PCR or rapid test).

Age in the registry: 55 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Nourah bint Abdulrahman University
Coordinator of this site? Confirm its status
RiyadhSaudi ArabiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.