Diabetes Clinical Trial
Official title:
Effect of Rebound Exercises and Circuit Training on Musculoskeletal Pain, Selected Biochemical and Psychosocial Parameters Among Individuals With Type 2 Diabetics
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. 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. 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. 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. 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. 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.
Summary of the proposed research methodology. The participants will be randomised into three
groups. The first group will be engaged in rebound exercise, the second group will be engaged
in circuit training while the third group will continue with their normal care of medication.
But before the commencement of the study, pilot study will be conducted on normal subjects.
Measurement will be carried out at the baseline, four weeks and at the end of the programme,
'The following parameters will be measured. Pain level, blood glycemic level of each
participant, cholesterol level, depression and quality of life.
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 resulting in increased
in diabetes and its 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.
Musculoskeletal (MSK) complications of diabetes mellitus (DM) are the most common endocrine
arthropathies. These have been generally under-recognized and poorly treated compared with
other complications, such as neuropathy, retinopathy, and nephropathy. These manifestations,
which are some of the causes of chronic disability. This involve not only the joints, but
also the bones and the soft tissues. In 2004, the National Health Interview Survey determined
that 58% of diabetic patients would have functional disability. The percentage of diabetic
patients with functional disability will increase as the number of diabetic patients
increases, and hence constitute a major public health problem. Recent data show that the
prevalence of MSK manifestations in the hands and shoulders in patients with type 1 or type 2
diabetes is 30%. These manifestations are closely linked to age, prolonged disease duration,
and vascular complications in the form of retinopathy.
Depression have been associated with diabetes these depressive symptoms are more likely to
persist among persons with multiple diabetic-related complications like musculoskeletal
disorders. 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.
Musculoskeletal disorders and disability are very common in diabetes and are associated with
worse glycemic control and more complications. Assessment of musculoskeletal disorders among
diabetes should include an estimate of cholesterol, glycemic control, pain, respiratory
parameters and quality of life. People with diabetes are twice at risk of suffering from
premorbid depression as the general population. The coexistence of depression in people with
diabetes catalyses serious disease comorbidities, MSK complications, decreased respiratory
capacity, poor glycemic control which may lead to hyperlipidemia and poor quality of life and
escalated healthcare expenditures.
Rebound exercise is the therapeutic movement on the mini trampoline, it moves all parts of
the body at once so it is also call a cellular exercise. It may be superior to any other
exercises because is not only uses gravity but also two other forces, acceleration and
deceleration at the top of the bounce you experience weightlessness, and at the bottom your
weight doubles pulling into the centre of the rebounder. While circuit training is
combination of strength training and aerobic exercises. Strengthening training exercises is a
resistance exercise that helps to keep the muscle flexible and strong and also strengthens
the bones. Aerobic exercise on the other hand is more vigorous exercises that increase oxygen
consumption, increase in oxygen consumption helps to burn more calories, stimulate immune
response and cardiovascular health.
Appropriate level of exercises such as rebound exercises can aid the management of type 2
diabetes and is likely to improve musculoskeletal Pain and depression. Circuit resistance
training has recently been documented to be a safe in the management of type 2 diabetics;
however, its effects on MSK pain and depression have not been assessed. Previous studies that
assessed resistance exercise with combined resistance and aerobic exercise sessions, showed
significant reductions in HbA1c. In contrast, other researchers did not observe any
favourable changes in fasting glucose or HbA1c in patients with type 2 diabetes and did not
assess its effect on MSK pain, respiratory parameters, depression and quality of life.
Rehabilitation can assist to retrain physical and functional abilities as well as
psychological emotions. Therefore, comprehensive rehabilitation to diabetes patients that
encompasses exercises like rebound and circuit training may improved glycemic functions and
reduces musculoskeletal functions and is very important to mitigate the negative impact has
on a person with diabetes.
Exercise has been documented as effective in the management of MSK pain, however there is no
consensus regarding the type of exercises that improve MSK pain, and if exercise is effective
in reducing depression and improvement in respiratory function among individuals with type 2
diabetes has not been documented.
STATEMENT OF PROBLEMS Diabetes mellitus (DM) is a multi-system disease characterized by
persistent hyperglycemia and has both acute and chronic biochemical and anatomical sequelae.
Type 2 DM represents approximately 90% of all cases of diabetes.
Previous studies have assessed the effect of resistance exercise with combined resistance and
aerobic exercise sessions on type 2 DM and showed significant reductions. However, Balagopal,
Kamalamma, Patel, & Misra, 2008 did not observe any favorable changes in fasting glucose or
HbA1c in patients with type 2 diabetes. Therefore, there is no consensus on the effect of
circuit resistance training (CRT) in type 2 diabetes. To the best of my knowledge, no
clinical trial has been conducted that compares the effect of rebound exercises and circuit
training on MSK pain, respiratory parameters and psychosocial variables among patients with
type 2 diabetes.
Cochrane review recommended that the features studies for the effect of exercises in the
management of type 2 diabetes should focus on quality of life, depression and effect on some
complication like musculoskeletal pain or disorders and cardiorespiratory fitness.
In African countries, there is a paucity of reports that describe MSK disabilities in
diabetic patients. To best of my knowledge no previous studies had been conducted to assess
the effect of any treatment of MSK manifestations in diabetic patients or to evaluate the
predisposing factors. This study is therefore proposed to determine the effect of rebound
exercises and circuit training on musculoskeletal pain, as well as selected biochemical and
psychosocial factors among individuals with type 2 diabetes.
RESARCH QUESTION 5. What is the effect of 8 weeks of rebound exercises training on glycemic
control, cholesterol level, respiratory parameters, pain scores, depression and quality of
life among type 2 diabetes patients? 6. What is the effect of 8 weeks of circuit resistance
training on glycemic control, cholesterol level, respiratory parameters, pain scores,
depression and quality of life among type 2 diabetes patients? 7. What is the effect of 8
weeks of routine care (control group) of medication and counselling as recommended by
international diabetic federation (IDF) on glycemic control, cholesterol level, respiratory
parameters, pain scores, depression and quality of life among type 2 diabetes patients? 8. Is
there any significant difference in glycemic control, cholesterol level, respiratory
parameters, pain scores, depression and quality of life among type 2 diabetes patients in the
control group, the rebound exercises group and the circuit resistance training group? AIMS
AND OBJECTIVES The major aim of this research is to investigate the effect of rebound
exercises and circuit training and compare them to the routine care of type 2 diabetic
patient Specific objectives of the study
1. To determine the effect of rebound exercises on glycemic control, cholesterol level,
respiratory parameters, pain scores, depression and quality of life among type 2
diabetes patients.
2. To determine the effect of circuit resistance training on glycemic control, cholesterol
level, respiratory parameters, pain scores, depression and quality of life among type 2
diabetes patients
3. To determine the effect of routine care (control group) on glycemic control, cholesterol
level, respiratory parameters, pain scores, depression and quality of life among type 2
diabetes patients.
4. To compare the effect of circuit training, rebound exercises and routine care on
glycemic control, cholesterol level, respiratory parameters, pain scores, depression and
quality of life among type 2 diabetes patients
5. Hypothesis
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
Significance of the study
The outcome of this study is expected to:
4. Provide additional strategy in glycemic control, cholesterol level, respiratory
parameters, musculoskeletal pain, depression and quality of life among type 2 diabetes
patients by promoting the use of exercises.
5. Show which exercise is the most effective in glycemic control, cholesterol level,
respiratory parameters, musculoskeletal pain, depression and quality of life among patients
with type 2 diabetes.
6. Give insight into the nature of musculoskeletal pain among type 2 diabetes patients.
Methods Ethical approval will be sought and obtained from University of KwaZulu-Natal
Biomedical research ethics committee, before the commencement of the study. Assessment of
participants will be conducted at three stages baseline, four week of intervention and at the
end of eight week of interventions. To ensure a comprehensive assessment, we chose a battery
of measures covering the WHO-ICF model. We selected certain tools to cover the three key
domains proposed by the ICF: body structures and function, activity and participation. At
baseline, participants will be assessed for socio-demographic characteristics which will
include personal demographic information and diabetes specific information. The personal
demographic information will include age, sex, height, weight, marital status, educational
qualification, employment. The diabetes specific information will include, type of diabetes.
At the baseline, the outcome measures to be used for these assessments are presented in the
measurement section.
Pilot study Pilot study will be conducted before the commencement of the study, the pilot
study will enable the researcher and the research assistant to familiarized them self with
the protocol of the intervention. The pilot study will involve two group the rebound
exercises group and the circuit training group, each group will have at least 10 participants
and they will be recruited from the gymnasium of the department of Biokinetic and
physiotherapy School of Health sciences, College of Health Sciences, University of
KwaZulu-Natal.
Participants The participants for the study will include patients diagnosed with type 2
diabetes, who will be screened for musculoskeletal pain using the Nordic musculoskeletal
symptoms questionnaire. They will also be screened for depression using the Beck Depression
Inventory (BDI). Only subjects with musculoskeletal symptoms and depression will be included
in the study. The consent of the subjects will be sought before they participate in the
study.
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