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

NCT06309654 | Completed DMC

• 1 other identifier: PNU
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Aerobic Exercise; Strength Training; Glycemic Control; Blood Pressure; Oxidative Stress; Metabolic Syndrome

Outcome Measures

Primary Outcomes (6)

• Blood pressure

  systolic (SBP) and diastolic (DBP) blood pressure

  end of 12 week

• The A1C test

  end of 12 week

• blood oxygen levels

  oxygen level was quantify using SpO2

  end of 12 week

• cardiorespiratory fitness

  a 6-minute walk test (6MWT)

  end of 12 week

• interleukin 6 (IL-6)

  an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine will be measured using Human ELISA Kit #P05231 and # P00441, respectively

  end of 12 week

• Superoxide dismutases (SOD)

  enzyme that alternately catalyzes the dismutation (or partitioning) of the superoxide will be measured using g Plasma IL-6 and SOD levels

  end of 12 week

Study Arms (2)

home-based circuit training (HBCT) protocol

EXPERIMENTAL

Participants in the exercise group performed HBCT three times per week on non-consecutive days for 12 weeks.

Behavioral: 12-week home-based circuit training (HBCT)

Standard of care (CONT)

SHAM COMPARATOR

Providing education about the nature of OA, its progression, and strategies for symptom management. Empowering individuals with self-management techniques, such as joint protection strategies, activity modification, and lifestyle changes (e.g., weight management, exercise).

Behavioral: Standard of care (CONT)

Interventions

12-week home-based circuit training (HBCT) BEHAVIORAL

Participants in the exercise group performed HBCT three times per week on non-consecutive days for 12 weeks. The first session was conducted at USM Hospital and participants were instructed how to perform the prescribed exercises in a correct form. In each session, participants performed seven exercises (two aerobic- and five resistance-based) in a circuit fashion, using bodyweight movements and adjustable dumbbells for varied weights, activating all the major muscle groups. In weeks 1-6, participants executed 15 repetitions for 2 rounds with 1 min passive rest between exercises and rounds. In weeks 7-12, participants executed 30 repetitions for 4 rounds with the same rest as prescribed in weeks 1-6. Each round lasted 10-15 min and the total session duration was 20-60 min, aiming to help participants adapt gradually to increasing training volume.

home-based circuit training (HBCT) protocol

Standard of care (CONT) BEHAVIORAL

Providing education about the nature of OA, its progression, and strategies for symptom management. Empowering individuals with self-management techniques, such as joint protection strategies, activity modification, and lifestyle changes (e.g., weight management, exercise).

Standard of care (CONT)

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• secondary KOA
• acute knee pain,
• changes in medication, supplementation, and/or diet
• changes in habitual physical activity
• smoking
• dementia or any psychiatric diseases
• adherence to less than 90% of total prescribed exercise sessions
• tested positive for COVID-19

Sponsors & Collaborators

• Princess Nourah Bint Abdulrahman University: lead

Study Sites (1)

Princess Nourah bint Abdulrahman University

Riyadh, 11671, Saudi Arabia

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sameer Al-Mhanna, Phd

  Department of physiology, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian 16150, Kelantan, Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 13, 2024
• Study Start: September 13, 2021
• Primary Completion: September 13, 2023
• Study Completion: December 29, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)