Effects of a Workplace Exercise Intervention on Cardio-Metabolic Health

NCT04403789 | Completed

• 1 other identifier: 23081010
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The rising levels of physical inactivity in the Eastern Mediterranean region (43.2%) and in the United Arab Emirates (38%) compared with the global levels of physical inactivity (31.2%) is alarming (6,15). Therefore, action is required to reduce physical inactivity using evidence-based strategies. This study aims to provide scientific evidence that if the workplace environment promotes behavior change, physical activity levels could increase and, therefore, improve health. Objective: Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. Secondary objective: to determine whether the workplace exercise intervention will improve physical activity levels even after 4 weeks of completing the intervention. Methods: A total of 150 participants will be recruited from a semi-government telecommunication company after meeting the eligibility criteria; 75 will be assigned to the intervention group and 75 to the delayed intervention group. Intervention: The Intervention group will receive 2 hours of exercise per week during working hours for 12 weeks. One hour can be used per day. The intervention group will be assigned to attend personal trainer sessions in the workplace gym during the intervention. After the intervention is completed the delayed intervention group will also receive 2 hours of exercise time per week from working hours for 4 weeks. Expected results: There is a statistically significant difference in the primary and secondary health outcome between the intervention group and delayed intervention group. Expected conclusion: Increasing exercise time in the workplace is associated with favorable cardio-metabolic risk profile.

Conditions

Cardiovascular Risk Factor; Pre Diabetes; High Blood Pressure; Elevated LDL Cholesterol

Keywords

cardiometabolic risk factors and exercise; workplace intervention

Outcome Measures

Primary Outcomes (5)

• Change from Baseline high Blood Pressure (mmHg) at 12 Weeks

  Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, high blood pressure. Measurement Criteria: Systolic blood pressure ≥ 130 mm Hg OR Diastolic blood pressure ≥ 85 mm Hg

  The outcome will be measured for both groups at baseline and after the 12-week intervention.

• Change from Baseline Waist Circumference (centimetres) at 12 Weeks

  Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, waist circumference above normal range. The waist circumference criteria are: Measurement Criteria: 1-Waist circumference above normal (cm): \> 102 cm for males and \> 88 cm for females (9)

  The outcome will be measured for both groups at baseline and after the 12-week intervention.

• Change from Baseline HDL-cholesterol (mmol/L) at 12 Weeks

  Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, elevated HDL-cholesterol. Measurement Criteria: \< 40 mg/dL in males and \< 50 mg/dL in females.

  The outcome will be measured for both groups at baseline and after the 12-week intervention.

• Change from Baseline Triglycerides (mg/dL) at 12 Weeks

  Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, Elevated Triglycerides (mg/dL) Measurement Criteria: • Elevated Triglycerides ≥ 150 (mg/dL)

  The outcome will be measured for both groups at baseline and after the 12-week intervention.

• Change from Baseline Fasting Plasma Glucose (mmol/L) at 12 Weeks

  Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. The cardio-metabolic risk components compromises of several risk factors including, pre-diabetes (Fasting plasma glucose). Measurement Criteria: 1-Pre-diabetes: Fasting plasma glucose (mg/dL) ≥ 100 mg/dL

  The outcome will be measured for both groups at baseline and after the 12-week intervention.

Secondary Outcomes (2)

• Change from Baseline Physical Activity (IPAQ Questionnaire) at 12 Weeks and 16 weeks

  This outcome will be measured for both groups at baseline, at 12-week intervention. The third measurement will be at 16 weeks (4 weeks after completing the intervention, for the intervention group only).

• Change from Baseline Physical Activity (AX3 Device) at 12 Weeks and 16 weeks

  This outcome will be measured for both groups at baseline, at 12-week intervention. The third measurement will be at 16 weeks (4 weeks after completing the intervention, for the intervention group only).

Study Arms (2)

Intervention Group

EXPERIMENTAL

During the intervention period they will receive 2 hours per week of group exercise sessions during working hours for 12 weeks. However, after the intervention period, there will be no change in working hours

Other: Exercise Time; Behavioral: Supervised Group Exercise

Delayed Intervention Group (Control group)

ACTIVE COMPARATOR

During the intervention period there will be no change in working hours. However, after the intervention period they will receive 2 hours of exercise time during working hours per week for 4 weeks

Other: Exercise Time

Interventions

Exercise Time OTHER

Employees will be provided with exercise time of 2 hours per week. The 2 hours should be used in two days. The intervention duration is 12 weeks.

Also known as: Working hours

Delayed Intervention Group (Control group); Intervention Group

Supervised Group Exercise BEHAVIORAL

The intervention group will receive 2-hours of exercise sessions per week under the supervision of a certified trainer in the gym workplace. The intervention duration is 12 weeks.

Also known as: Group exercise sessions

Intervention Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be an employee in the company and have at least a waist circumference of ≥94 cm (≥90 cm for South and East Asians) for males and ≥ 80 cm for females.
• Aged 18 to 59 years old.
• Availability of the participants for the study duration.
• Participant is willing to commit to the intervention until the end.
• Signed written consent to participate.

You may not qualify if:

• Severe injury in the joints or the back or any medical condition that would prevent them from exercising, or the participant is advised not to exercise by a doctor.
• Pregnant.
• Any planned major surgical procedures during the intervention period.
• Self-reported cardiovascular disease, lung disease, or cancer.
• Currently participating in a health promotion program

Sponsors & Collaborators

• United Arab Emirates University: lead
• Mohammed Bin Rashid University of Medicine and Health Sciences: collaborator

Study Sites (1)

Emirates Integrated Telecommunication Company (Du), Headquarters Building.

Dubai, Dubai Internet City, United Arab Emirates

Location

Related Publications (16)

• Axivity Ltd. AX3 [Internet]. AX3. 2019 [cited 2019 Jun 16]. Available from: http://www.axivity.com/product/1

  BACKGROUND

• Bergman F, Wahlstrom V, Stomby A, Otten J, Lanthen E, Renklint R, Waling M, Sorlin A, Boraxbekk CJ, Wennberg P, Ohberg F, Levine JA, Olsson T. Treadmill workstations in office workers who are overweight or obese: a randomised controlled trial. Lancet Public Health. 2018 Nov;3(11):e523-e535. doi: 10.1016/S2468-2667(18)30163-4. Epub 2018 Oct 12.

  PMID: 30322782 BACKGROUND

• Cannon CP. Cardiovascular disease and modifiable cardiometabolic risk factors. Clin Cornerstone. 2007;8(3):11-28. doi: 10.1016/s1098-3597(07)80025-1.

  PMID: 18452839 BACKGROUND

• Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.

  PMID: 30586774 BACKGROUND

• Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1046-e1081. doi: 10.1161/CIR.0000000000000624. Epub 2018 Nov 10. No abstract available.

  PMID: 30565953 BACKGROUND

• Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1.9 million participants. Lancet Glob Health. 2018 Oct;6(10):e1077-e1086. doi: 10.1016/S2214-109X(18)30357-7. Epub 2018 Sep 4.

  PMID: 30193830 BACKGROUND

• International Physical Activity Questionnaire. IPAQ scoring protocol - International Physical Activity Questionnaire [Internet]. 2005 [cited 2019 Jan 27]. Available from: https://sites.google.com/site/theipaq/scoring-protocol

  BACKGROUND

• Irving BA, Davis CK, Brock DW, Weltman JY, Swift D, Barrett EJ, Gaesser GA, Weltman A. Effect of exercise training intensity on abdominal visceral fat and body composition. Med Sci Sports Exerc. 2008 Nov;40(11):1863-72. doi: 10.1249/MSS.0b013e3181801d40.

  PMID: 18845966 BACKGROUND

• Klein S, Allison DB, Heymsfield SB, Kelley DE, Leibel RL, Nonas C, Kahn R; Association for Weight Management and Obesity Prevention; NAASO; Obesity Society; American Society for Nutrition; American Diabetes Association. Waist circumference and cardiometabolic risk: a consensus statement from shaping America's health: Association for Weight Management and Obesity Prevention; NAASO, the Obesity Society; the American Society for Nutrition; and the American Diabetes Association. Diabetes Care. 2007 Jun;30(6):1647-52. doi: 10.2337/dc07-9921. Epub 2007 Mar 14. No abstract available.

  PMID: 17360974 BACKGROUND

• Molmen-Hansen HE, Stolen T, Tjonna AE, Aamot IL, Ekeberg IS, Tyldum GA, Wisloff U, Ingul CB, Stoylen A. Aerobic interval training reduces blood pressure and improves myocardial function in hypertensive patients. Eur J Prev Cardiol. 2012 Apr;19(2):151-60. doi: 10.1177/1741826711400512. Epub 2011 Mar 4.

  PMID: 21450580 BACKGROUND

• Nichols GA, Horberg M, Koebnick C, Young DR, Waitzfelder B, Sherwood NE, Daley MF, Ferrara A. Cardiometabolic Risk Factors Among 1.3 Million Adults With Overweight or Obesity, but Not Diabetes, in 10 Geographically Diverse Regions of the United States, 2012-2013. Prev Chronic Dis. 2017 Mar 9;14:E22. doi: 10.5888/pcd14.160438.

  PMID: 28278130 BACKGROUND

• Tomeleri CM, Ribeiro AS, Souza MF, Schiavoni D, Schoenfeld BJ, Venturini D, Barbosa DS, Landucci K, Sardinha LB, Cyrino ES. Resistance training improves inflammatory level, lipid and glycemic profiles in obese older women: A randomized controlled trial. Exp Gerontol. 2016 Nov;84:80-87. doi: 10.1016/j.exger.2016.09.005. Epub 2016 Sep 9.

  PMID: 27616162 BACKGROUND

• Tomeleri CM, Souza MF, Burini RC, Cavaglieri CR, Ribeiro AS, Antunes M, Nunes JP, Venturini D, Barbosa DS, Sardinha LB, Cyrino ES. Resistance training reduces metabolic syndrome and inflammatory markers in older women: A randomized controlled trial. J Diabetes. 2018 Apr;10(4):328-337. doi: 10.1111/1753-0407.12614. Epub 2017 Dec 11.

  PMID: 29031002 BACKGROUND

• WHO. WHO | Waist circumference and waist-hip ratio [Internet]. WHO. 2008 [cited 2018 Dec 12]. Available from: http://www.who.int/nutrition/publications/obesity/WHO_report_waistcircumference_and_waisthip_ratio/en/

  BACKGROUND

• WHO. United Arab Emirates health profile 2015 [Internet]. 2016. Available from: http://applications.emro.who.int/dsaf/EMROPUB_2016_EN_19276.pdf

  BACKGROUND

• Alrahma AM, Habib MA, Oulhaj A, Loney T, Boillat T, Shah SM, Ahmed LA, Nauman J. Effects of a workplace exercise intervention on cardiometabolic health: study protocol for a randomised controlled trial. BMJ Open. 2021 Nov 3;11(11):e051070. doi: 10.1136/bmjopen-2021-051070.

  PMID: 34732483 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Hypertension; Hyperlipoproteinemia Type II; Motor Activity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Behavior

Study Officials

• Javaid Nauman, PhD

  United Arab Emirates University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding was used. The intervention group was renamed Group A and the delayed-intervention group as Group B to blind participants from the intervention. Participants were strongly encouraged not to disclose their allocation status during the health measurement assessments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Intervention The intervention duration is 12 weeks and it will provide the employees exercise time of 2 hours per week. The 2 hours should be used in two days either at the middle or at the end of working hours. The 2-hours exercise session will be conducted under the supervision of a certified trainer in the gym workplace. The 12 weeks period was chosen based on recommendations from previous studies to examine the effect of exercise interventions. The delayed intervention group will be asked to perform their usual routine and continue their usual exercise/physical activity routines. However, after the intervention is completed the delayed intervention group will also receive 2 hours of exercise time per week from working hours for 4 weeks. The reason for this is to encourage participants to participate in the study regardless of which group they will be assigned in. Also, this will help us reduce contamination as participants will not be aware which group they were assigned in.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 27, 2020
• Study Start: March 28, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data availability begins one year after publication. Data availability ends three years after publications
• Access Criteria: To researchers who provide a methodologically sound proposal and has approval from Dubai Scientific Research Ethics Committee in Dubai Health Authority.

Locations

AE (1)