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Aerobic ExerciseNCT06309654

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

A study testing 12-week home-based circuit training (HBCT) in people with Aerobic Exercise and Strength Training, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 55 to 75 years
What is being tested?
12-week home-based circuit training (HBCT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteSaudi Arabia
Study dates
13 Sep 2021to 29 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Princess Nourah bint Abdulrahman University

    Riyadh, 11671

Other trials in Saudi Arabia

About this study

Official title: 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

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.

Read the 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, overweight/obese 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 >7.0 mmol·L-1 and glycated hemoglobin (HbA1c) >6.5%, vi) overweight or obesity (BMI ≥25 kg/m2), 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, and/or 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 [e.g., resting heart rate (RHR), systolic (SBP) and diastolic (DBP) blood pressure], BMI, biomarkers [e.g., 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.

Being tested
12-week home-based circuit training (HBCT), Standard of care (CONT)
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 12-week home-based circuit training (HBCT)Behavioural

    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.

  • Standard of care (CONT)Behavioural

    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).

Study groups in NCT06309654
Study groupRoleWhat they receive
home-based circuit training (HBCT) protocolExperimentalParticipants in the exercise group performed HBCT three times per week on non-consecutive days for 12 weeks.
Receives: Behavioral: 12-week home-based circuit training (HBCT)
Standard of care (CONT)Sham comparatorProviding 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).
Receives: Behavioral: Standard of care (CONT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure

    systolic (SBP) and diastolic (DBP) blood pressure

    Measured: end of 12 week

  2. The A1C test

    Measured: end of 12 week

  3. blood oxygen levels

    oxygen level was quantify using SpO2

    Measured: end of 12 week

  4. cardiorespiratory fitness

    a 6-minute walk test (6MWT)

    Measured: end of 12 week

  5. 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

    Measured: end of 12 week

  6. 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

    Measured: end of 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start13 Sep 2021
  3. Primary completion13 Sep 2023
  4. Study completion29 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06309654
Sponsor's protocol ID
PNU
Status last verified
Mar 2024
First submitted
1 Mar 2024
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 12-week home-based circuit training (HBCT) in people with Aerobic Exercise and Strength Training, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure (time frame: end of 12 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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