Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309654
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-03-01
Brief Title:
Home-Based Circuit Training in OverweightObese Older Adult Patients With Knee Osteoarthritis and Type 2 Diabetes
Sponsor:
Princess Nourah Bint Abdulrahman University
Organization:
Princess Nourah Bint Abdulrahman University
Study Overview
Official Title:
Home-Based Circuit Training Attenuates Cardiovascular Risk and Amplifies Functionality and Quality of Life in OverweightObese Older Adult Patients With KOA and Type 2 Diabetes A Randomized Controlled Trial During the COVID-19
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 overweightobese older adult patients with KOA and T2DM during the COVID-19 lockdown Methods Seventy overweight or obese patients with KOA and T2DM 622 61 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 p005 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 overweightobese 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
Detailed Description:
Introduction Despite the beneficial exercise training-induced adaptations the optimal exercise strategy for populations with obesity T2DM and knee osteoarthritis KOA presents with some shortcomings in the current literature More importantly there are no explicit exercise recommendations in the current KOA guidelines Kolasinski et al 2020 Hence this pragmatic trial was carried out in a home-based setting aiming to principally investigate the effectiveness of a 12-week home-based circuit training HBCT protocol on various outcomes related to knee osteoarthritis symptoms and cardiometabolic health among previously inactive overweightobese older adult patients with KOA and T2DM in the real world
Methods A total of 35 participants were required for this study after considering a dropout rate of 20 This study involved 69 patients meeting the inclusion criteria as follows i age 55 years ii diagnosed with KOA with Kellgren-Lawrence criteria grades 2 and 3 indicating moderate KOA which was based on radiological assessments conducted by a traumatologist iv chronic knee pain for more than three months v T2DM based on fasting plasma glucose 70 mmolL-1 and glycated hemoglobin HbA1c 65 vi overweight or obesity BMI 25 kgm2 vii receiving the standard treatment all patients were taking diabetes medications and viii providing a certificate of a negative COVID-19 diagnostic test PCR or rapid test Patients were excluded from the study if during the intervention they demonstrated i secondary KOA ii acute knee pain iii changes in medication supplementation andor diet iv changes in habitual physical activity v intraarticular hyaluronic acid injection treatment within one year vi smoking vii dementia or any psychiatric diseases viii adherence to less than 90 of total prescribed exercise sessions or ix they tested positive for COVID-19 After informed written consent patients were asked not to engage in any other forms of exercise and to maintain their current habitual physical activity levels and eating patterns throughout a 3-month intervention period Thus the participants logbook was reviewed at each visit aiming to ensure that no changes in nutritional behavior and physical activity patterns occurred CON followed standard treatment diabetes medications without engaging in any structured exercise throughout the intervention
Study design This is a pragmatic randomized controlled trial study registered at the National Medical Research Register ID RSCH ID-21-01180-KGTNMRR ID-21-02367-FUM The patients were recruited via a poster distributed in the Orthopedics Clinic at USM Hospital Written informed consent was obtained from all participants before the study Those willing to participate were then selected and randomly assigned to CON or HBCT More specifically patients were divided into two groups performed by an independent statistician using computer-generated random allocation sequences
Assessment procedures All patients were instructed to avoid consuming caffeinated beverages and strenuous exercise 24 hours before the first visit A total of three visits were performed and all outcomes were assessed through the three visits baseline weeks 6 and 12 All measurements were performed at USM Hospital During the first visit baseline assessments were carried out for cardiovascular parameters eg resting heart rate RHR systolic SBP and diastolic DBP blood pressure BMI biomarkers eg HbA1c interleukin 6 IL-6 and superoxide dismutases SOD rate of perceived exertion RPE blood oxygen levels SpO2 and a 6-minute walk test 6MWT to assess cardiorespiratory fitness CRF KOA symptoms and comorbidity score were also assessed During the second visit at week 6 mid-testing an assessment of cardiovascular parameters and KOA symptoms RPE SpO2 and 6MWT took place During the third visit at week 12 post-testing similar assessments to those conducted at baseline were carried out
Methods A total of 35 participants were required for this study after considering a dropout rate of 20 This study involved 69 patients meeting the inclusion criteria as follows i age 55 years ii diagnosed with KOA with Kellgren-Lawrence criteria grades 2 and 3 indicating moderate KOA which was based on radiological assessments conducted by a traumatologist iv chronic knee pain for more than three months v T2DM based on fasting plasma glucose 70 mmolL-1 and glycated hemoglobin HbA1c 65 vi overweight or obesity BMI 25 kgm2 vii receiving the standard treatment all patients were taking diabetes medications and viii providing a certificate of a negative COVID-19 diagnostic test PCR or rapid test Patients were excluded from the study if during the intervention they demonstrated i secondary KOA ii acute knee pain iii changes in medication supplementation andor diet iv changes in habitual physical activity v intraarticular hyaluronic acid injection treatment within one year vi smoking vii dementia or any psychiatric diseases viii adherence to less than 90 of total prescribed exercise sessions or ix they tested positive for COVID-19 After informed written consent patients were asked not to engage in any other forms of exercise and to maintain their current habitual physical activity levels and eating patterns throughout a 3-month intervention period Thus the participants logbook was reviewed at each visit aiming to ensure that no changes in nutritional behavior and physical activity patterns occurred CON followed standard treatment diabetes medications without engaging in any structured exercise throughout the intervention
Study design This is a pragmatic randomized controlled trial study registered at the National Medical Research Register ID RSCH ID-21-01180-KGTNMRR ID-21-02367-FUM The patients were recruited via a poster distributed in the Orthopedics Clinic at USM Hospital Written informed consent was obtained from all participants before the study Those willing to participate were then selected and randomly assigned to CON or HBCT More specifically patients were divided into two groups performed by an independent statistician using computer-generated random allocation sequences
Assessment procedures All patients were instructed to avoid consuming caffeinated beverages and strenuous exercise 24 hours before the first visit A total of three visits were performed and all outcomes were assessed through the three visits baseline weeks 6 and 12 All measurements were performed at USM Hospital During the first visit baseline assessments were carried out for cardiovascular parameters eg resting heart rate RHR systolic SBP and diastolic DBP blood pressure BMI biomarkers eg HbA1c interleukin 6 IL-6 and superoxide dismutases SOD rate of perceived exertion RPE blood oxygen levels SpO2 and a 6-minute walk test 6MWT to assess cardiorespiratory fitness CRF KOA symptoms and comorbidity score were also assessed During the second visit at week 6 mid-testing an assessment of cardiovascular parameters and KOA symptoms RPE SpO2 and 6MWT took place During the third visit at week 12 post-testing similar assessments to those conducted at baseline were carried out
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None