Effect of Different Exercises on Musculoskeletal Pain,Glucose Level and Quality of Life Among Patients With Diabetes

NCT03200795 | Unknown

• 1 other identifier: 4198
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Diabetes is a global epidemic disease. The prevalence of diabetes for all age groups worldwide was estimated to be 2.8% in 2000 and is predicted to affect 4.4% by 2030. The global prevalence of diabetics is currently estimated to be 285 million and projection rates are expected to rise to over 438 million by the year 2030, with Asians suffering the bulk of the total diabetes epidemic. The incidence of chronic diseases of lifestyle such as Type 2 Diabetes Mellitus (DM) is on the increase amongst the South African population. Due to the numerous factors such as lack of education, inaccessibility of healthcare facilities and/or poor socio-economic background, diabetes mellitus often goes undetected in rural areas, resulting in an increase in musculoskeletal complication and other diabetes mellitus complications. Inability to control blood sugar may induce serious complications such as renal disease, peripheral neuropathy, retinopathy, and vascular events. Due to its multi-systemic nature, diabetes will lead to the development of additional manifestations such as musculoskeletal complications, reduces respiratory capacity, depression and poor quality of life. Studies have shown that both exercises and pharmacotherapy can decreases depression and improved glycemic control and overall quality of life of persons with diabetes. Thus, in addition improve the quality of life and substantial financial savings and improved medical care of these individuals. Hypothesis

1. 1.There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients at the baseline and at the end of 8 weeks of rebound exercises.
2. 2.There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients at the baseline and at the end of 8 weeks of circuit resistance training.
3. 3.There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients at the baseline and at the end of 8 weeks of routine care.
4. 4.There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients between the rebound exercises group, circuit training and routine care at the baseline.
5. 5.There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients between the rebound exercises group, circuit training and routine care at the end of 8 week of the programme.

Conditions

Diabetes

Keywords

Diabetes; Musculoskelatal pain; Rebound exercises; Depression; Glucose; Quality of life

Outcome Measures

Primary Outcomes (3)

• Pain Change is being assessed

  Musculoskeletal pain will be assess, using visual analog scale (VAS)

  Baseline and at the end of eight week of the study

• Blood glucose level Change is being assessed

  The sugar level will be measure using accutrend plus

  Baseline and at the end of eight week of the study

• Cholesterol level Change is being assessed

  The cholesterol level will be measure using accutrend pus

  Baseline and at the end of eight week of the study

Secondary Outcomes (2)

• Depression Change is being assessed

  Baseline and at the end of the eight week of the study

• Quality of life Change is being assessed

  Baseline and at the end of the eight week of the study

Study Arms (2)

Rebound exercise group

EXPERIMENTAL

Participants randomized to this group will be instructed on the proper techniques of the desired movements (hopping) on the rebounder.

Other: Rebound exercise

Circuit training group

EXPERIMENTAL

The circuit training for the participants in this group will be designed for each participant. Training will take place 3 times a week for 8 weeks. The participants will undergo 10 minutes warm up before and 10 minutes cool down after the training. Resistance exercises will be performed on weight machines. Throughout the resistance training program, participants will be alternating between the bench press, seated row, lateral pull down, biceps forward, front thigh, back thigh, leg press and rowing.

Other: Circuit training exercise

Interventions

Rebound exercise OTHER

Each participant will undergo 3 sessions a week for 8 weeks with each session lasting 20 minutes. Bouncing frequency will be determined by signals from an metronom and will be set at between 90 and 120 bounces per minute. Heart rate training zone will be maintained, during the exercise, at moderate intensity of 40-60% and will be calculated using the Karvonen formula (\[Heart rate reserve x training percentage\] + resting heart rate)(Nuhu \& Maharaj, 2017). The exercise will involve bouncing on the center portion of the mini trampoline (Portable 2013 Model Half-Fold Cellerciser with feet slightly apart and knees in full extension. Each foot strike equaled one step or bounce with step height, this will be defined as the distance between the foot at maximum height of jump and the bed of the center of the trampoline ranging between 10 and 15 cm (Nuhu \& Maharaj, 2017).

Rebound exercise group

Circuit training exercise OTHER

Participants will be instructed to exhale while lifting a weight and inhale while lowering it, to minimize blood pressure excursions, and to rest for 2 to 3 minutes between sets. Participants will perform 1 set per resistance exercise three time weekly for the first 2 weeks and 4 sets of each resistance exercise three time weekly during weeks 3 and 4. Resistance will be increase by 5 to 10 kg when the participant could perform more than 15 repetitions while maintaining proper form. All aerobic activities of the circuit training will be performed on a cycle ergometer or treadmill. Participants are free to vary the machine used from one visit to the next. Exercise intensity will be standardized by using heart rate monitors (Polar Electro Oy) that will display the participant's heart rate and emitted a warning signal when the heart rate was outside the prescribed training zone, thus guiding the participant in adjusting the workload up or down to achieve the desired intensity.

Circuit training group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with diagnosis of type 2 diabetes for at least 4 years on oral hypoglycemic control
• Age between 20 to 55 years
• Musculoskeletal affectation and depression,
• Consent to participate in the study.

You may not qualify if:

• Subjects who are involved in sporting activities
• Those whose musculoskeletal problems are severe and may prevent them from performing some of the exercises.
• Individuals with hypertension
• Coronary artery disease
• Myocardial infarction
• Cardiac or abdominal surgery
• Previous 6 months, history of fractures of the spine, hip, knee and ankle joints
• Lower limb weakness and deformities with loss of protective sensation in the feet.
• Pregnancy or lactation
• Use of insulin
• Presence of retinopathy,
• Nephropathy
• Subjects who do not consent to participate.

Sponsors & Collaborators

• University of KwaZulu: lead

Study Sites (1)

Aminu Kano Teaching Hospital

Kano, 70000, Nigeria

RECRUITING

Related Publications (10)

• Misra A, Alappan NK, Vikram NK, Goel K, Gupta N, Mittal K, Bhatt S, Luthra K. Effect of supervised progressive resistance-exercise training protocol on insulin sensitivity, glycemia, lipids, and body composition in Asian Indians with type 2 diabetes. Diabetes Care. 2008 Jul;31(7):1282-7. doi: 10.2337/dc07-2316. Epub 2008 Mar 3.

  PMID: 18316394 BACKGROUND

• Maharaj, S. S., & Nuhu, J. M. (2015). The effect of rebound exercise and treadmill walking on the quality of life for patients with non-insulin-dependent type 2 diabetes. International Journal of Diabetes in Developing Countries, 35(October), 223-229. https://doi.org/10.1007/s13410-015-0350-z

  BACKGROUND

• Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.

  PMID: 8991972 BACKGROUND

• Arora E, Shenoy S, Sandhu JS. Effects of resistance training on metabolic profile of adults with type 2 diabetes. Indian J Med Res. 2009 May;129(5):515-9.

  PMID: 19675378 BACKGROUND

• Cohen, J. (1977). Statistical power analysis for the behavioral sciences. Academic Press.

  BACKGROUND

• Odole, A. C., & Akinpelu, A. O. (2009). Translation and Alternate Forms Reliability of the Visual Analogue Scale in the Three Major Nigerian Languages. Pain, 7(3), 1-7.

  BACKGROUND

• Pai LW, Hung CT, Li SF, Chen LL, Chung Y, Liu HL. Musculoskeletal pain in people with and without type 2 diabetes in Taiwan: a population-based, retrospective cohort study. BMC Musculoskelet Disord. 2015 Nov 20;16:364. doi: 10.1186/s12891-015-0819-4.

  PMID: 26589716 BACKGROUND

• International Diabetes Federation. (2013). IDF Diabetes Atlas. Hallado en: http://www. idf. org/diabetesatlas/5e/es/ …

  BACKGROUND

• Who. (2001). The International Classification of Functioning, Disability and Health. World Health Organization, 18, 237. https://doi.org/10.1097/01.pep.0000245823.21888.71

  BACKGROUND

• Kaka B, Maharaj SS. Effect of Rebound Exercises and Circuit Training on Complications Associated with Type 2 Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 May 7;7(5):e124. doi: 10.2196/resprot.8827.

  PMID: 29735476 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Depression

Interventions

Circuit-Based Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Sonill Maharaj, PhD

CONTACT

+27834611413; maharajss@ukzn.ac.za

Jeanne Grace, PhD

CONTACT

+27832331523; grace@ukzn.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: To eliminate bias, the assessment of outcome will be performed by (experienced) blinded assessors, who will be blinded to the type of intervention as well as the intervention groups of the participants. Participants will also be instructed not to disclose their individual intervention groups to the assessors
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be 3 group, the rebound exercise group, circuit training group and the control group. The rebound exercises group will received rebound exercise therapy while circuit training will received circuit exercises that comprises progressive resistance exercise and aerobic exercises, while control group will be treated based on the guideline of the management of diabetes by international diabetes federation. Also the two exercise group will received their routine care plus exercises.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 27, 2017
• Study Start: March 15, 2018
• Primary Completion: November 20, 2018
• Study Completion: February 20, 2019
• Last Updated: May 8, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)