Comparing the Effects of Aerobic & Resistance Exercises and Vitamins D & E on Oxidative Stress & Inflammatory Markers Among Patients with Depression
NCT ID: NCT06775548
Last Updated: 2025-01-15
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
NA
116 participants
INTERVENTIONAL
2024-09-02
2025-08-05
Brief Summary
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The primary etiology of MDD is disturbances in neurotransmitters and neuroendocrine regulation, accompanied by a complex interaction of genetic and environmental factors. In addition to these factors, increasing attention has been directed towards understanding the pathophysiology of MDD through the relationship between oxidative stress and inflammation. Essential enzymatic antioxidants, particularly Glutathione Peroxidase (GPx) and Superoxide Dismutase (SOD), play a crucial role in moderating oxidative stress. Oxidative stress arises from an imbalance between the generation of reactive oxygen species (ROS) and the body's capacity to counteract them. Studies indicate a tendency for reduced GPx and SOD activity in individuals with MDD, leading to heightened oxidative stress.
Furthermore, the involvement of pro-inflammatory cytokines, such as Tumor Necrosis Factor-alpha (TNF) and Interleukin-6 (IL-6), in the inflammatory processes associated with depression is noteworthy. Persistent inflammation is associated with the activation of the kynurenine pathway, triggering the production of neurotoxic metabolites that may contribute to observed neurobiological changes in MDD. Elevated levels of TNF and IL-6, key immune response mediators, are observed in individuals with depression. These cytokines influence neurotransmitter metabolism, disrupt the blood-brain barrier, and activate microglia, spreading neuro-inflammation. The bidirectional interplay between oxidative stress and inflammation establishes a cyclically reinforcing paradigm, amplifying the neurobiological substrates of depression.. Moreover, deficiencies in various vitamins and minerals are significantly associated with Major Depressive Disorder (MDD), including vitamin D and E. Vitamin D and its metabolite calcitriol may act as a defense mechanism for the brain, guarding against the depletion of dopamine and serotonin whereas vitamin E has an antidepressant-like effect.
The management of major depressive disorder encompasses diverse treatment approaches, comprising pharmacological, psychotherapeutic, interventional, and lifestyle modifications, such as incorporating exercise and dietary changes. While the current antidepressants are more effective than placebos in adults with MDD, limitations of antidepressant treatment include a prolonged therapeutic time lag required for the clinical betterment of depressive symptoms and various side effects linked to their usage. These side effects frequently lead to treatment discontinuation by patients. Consequently, adjunctive treatments may play a crucial role in managing this disorder, particularly in cases of treatment resistance.
Engaging in regular exercise exerts a beneficial impact on symptoms commonly associated with depression. The consistent practice of physical activity positively influences various physiological aspects, encompassing neurotransmitter levels, neurotrophic factors, hormonal balance, immune modulation, sleep quality, and cognitive functions. This comprehensive influence collectively provides substantial evidence for the therapeutic effectiveness of exercise in alleviating depressive symptoms. Hence, the objective of the current study is to investigate the outcomes of aerobic and resistance exercises in conjunction with vitamin supplementation on individuals diagnosed with Major Depressive Disorder (MDD).
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Detailed Description
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Participants in Group-A will be receiving Aerobic Exercise with Vitamin E, Group-B participants will be receiving Resistance Exercise with Vitamin E, Group C: Aerobic Exercise with Vitamin D, while Group D will be receiving Resistance Exercise with Vitamin D. Whereas, all the groups will be given 48 sessions of their respective protocol, comprising of 30 minutes, 4 times/week for the duration of 12 weeks.
Participants referred to the study will undergo a thorough screening process as discussed below to determine their eligibility.
The recruitment of patients will be conducted by a psychiatrist, adhering to predefined inclusion and exclusion criteria. Patients will undergo screening and be categorized as having Major Depressive Disorder (MDD) if they exhibit at least one of the two primary criteria-depressed mood or anhedonia (the inability to experience pleasure or loss of interest)-along with four or more secondary symptoms persisting for a minimum period of 2 weeks, as per DSM-5 guidelines (American Psychiatric Association, 2013).
They will then be screened through PARQ \& YOU questionnaire by physical therapist. Subsequently, the investigator will provide a comprehensive overview of the study to the patients and secure informed consent upon their agreement. Demographic information and pertinent variables, including the duration of the disease and comorbidities, will be documented before the baseline assessment. All patients will adhere to their routine pharmacological care throughout the intervention period.
An orientation session will be arranged before starting the intervention in which the physical therapists in detailed will brief the participants regarding the protocol. The intervention will last for duration of 12 weeks with a total of 48 sessions. First, the participant will perform 1 week of training as part of familiarization phase.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Group A
Aerobic Exercises with Vitamin E
Aerobic Exercises + Vitamin E
For aerobic exercise, patient will perform cycling. The patient will perform stationary bike with an intensity of 60-85% of MHR by using Karvonean formula for duration of 30 minutes for 4 days/ week. Participants will be advised by the physical therapist to sit on a cycle ergometer with back supported, hands holding the handle bar and feet firmly placed on the pedals.
The imprint of FITT protcol by ACSM for aerobic exercise will be as follows, Frequency: 4 days/week Intensity: 60-85% of MHR Time: 30 minutes Type: Stationary bike
Group B
Resistance Exercises with Vitamin E
Resistance Exercises + Vitamin E
The strength training protocol will focus on 10 major muscles of the body. The sessions will be performed for 4 days per week, lasting approximately 30 minutes. The training will be divided in a systematical manner, on first- and third-day participant will perform strength training of upper limb and abdominal muscles that include: Biceps, Triceps, Pectoralis Major, Deltoid, and abdominal muscles. On second and fourth day, participant will perform strength training of lower back and lower limb muscles that include: Latissimus Dorsi, Abdominals, Back Extensors, Hamstrings, Quadriceps and Calf. The intensity of the weight bearing exercises will be calculated using 1 Repetition Maximum (RM) method. The protocol will be divided as follows: 2 days the participant will perform exercises for upper limb and 2 days, patient will perform exercises for lower limb.
Group C
Aerobic Exercises with Vitamin D
Aerobic Exercises + Vitamin D
For aerobic exercise, patient will perform cycling. The patient will perform stationary bike with an intensity of 60-85% of MHR by using Karvonean formula for duration of 30 minutes for 4 days/ week. Participants will be advised by the physical therapist to sit on a cycle ergometer with back supported, hands holding the handle bar and feet firmly placed on the pedals. The imprint of FITT protcol by ACSM for aerobic exercise will be as follows, Frequency: 4 days/week Intensity: 60-85% of MHR Time: 30 minutes Type: Stationary bike
Group D
Resistance Exercises with Vitamin D
Resistance Exercises + Vitamin D
The strength training protocol will focus on 10 major muscles of the body. The sessions will be performed for 4 days per week, lasting approximately 30 minutes. The training will be divided in a systematical manner, on first- and third-day participant will perform strength training of upper limb and abdominal muscles that include: Biceps, Triceps, Pectoralis Major, Deltoid, and abdominal muscles. On second and fourth day, participant will perform strength training of lower back and lower limb muscles that include: Latissimus Dorsi, Abdominals, Back Extensors, Hamstrings, Quadriceps and Calf. The intensity of the weight bearing exercises will be calculated using 1 Repetition Maximum (RM) method. The protocol will be divided as follows: 2 days the participant will perform exercises for upper limb and 2 days, patient will perform exercises for lower limb.
Interventions
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Aerobic Exercises + Vitamin E
For aerobic exercise, patient will perform cycling. The patient will perform stationary bike with an intensity of 60-85% of MHR by using Karvonean formula for duration of 30 minutes for 4 days/ week. Participants will be advised by the physical therapist to sit on a cycle ergometer with back supported, hands holding the handle bar and feet firmly placed on the pedals.
The imprint of FITT protcol by ACSM for aerobic exercise will be as follows, Frequency: 4 days/week Intensity: 60-85% of MHR Time: 30 minutes Type: Stationary bike
Resistance Exercises + Vitamin E
The strength training protocol will focus on 10 major muscles of the body. The sessions will be performed for 4 days per week, lasting approximately 30 minutes. The training will be divided in a systematical manner, on first- and third-day participant will perform strength training of upper limb and abdominal muscles that include: Biceps, Triceps, Pectoralis Major, Deltoid, and abdominal muscles. On second and fourth day, participant will perform strength training of lower back and lower limb muscles that include: Latissimus Dorsi, Abdominals, Back Extensors, Hamstrings, Quadriceps and Calf. The intensity of the weight bearing exercises will be calculated using 1 Repetition Maximum (RM) method. The protocol will be divided as follows: 2 days the participant will perform exercises for upper limb and 2 days, patient will perform exercises for lower limb.
Aerobic Exercises + Vitamin D
For aerobic exercise, patient will perform cycling. The patient will perform stationary bike with an intensity of 60-85% of MHR by using Karvonean formula for duration of 30 minutes for 4 days/ week. Participants will be advised by the physical therapist to sit on a cycle ergometer with back supported, hands holding the handle bar and feet firmly placed on the pedals. The imprint of FITT protcol by ACSM for aerobic exercise will be as follows, Frequency: 4 days/week Intensity: 60-85% of MHR Time: 30 minutes Type: Stationary bike
Resistance Exercises + Vitamin D
The strength training protocol will focus on 10 major muscles of the body. The sessions will be performed for 4 days per week, lasting approximately 30 minutes. The training will be divided in a systematical manner, on first- and third-day participant will perform strength training of upper limb and abdominal muscles that include: Biceps, Triceps, Pectoralis Major, Deltoid, and abdominal muscles. On second and fourth day, participant will perform strength training of lower back and lower limb muscles that include: Latissimus Dorsi, Abdominals, Back Extensors, Hamstrings, Quadriceps and Calf. The intensity of the weight bearing exercises will be calculated using 1 Repetition Maximum (RM) method. The protocol will be divided as follows: 2 days the participant will perform exercises for upper limb and 2 days, patient will perform exercises for lower limb.
Eligibility Criteria
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Inclusion Criteria
* Individuals both with and without current psychoactive medication (such as antidepressants or anxiolytics) will be enrolled. (O'Sullivan et al., 2023)
* Participants willing to participate to the intervention.
Exclusion Criteria
* Participants with pregnant women,
* Participants with use of beta-blockers,
* Participants with a history of severe mental illnesses (mentally handicapped),
* Participants with hypertension, hyperparathyroidism,
* Participants with current significant substance or alcohol abuse, ongoing burn-out syndrome, and
* Participants with An elevated suicide risk determined by the Psychiatrist.
* Participants with Prisoners
* Participants with chronic diseases such as liver and renal diseases, mal-absorption syndrome, and other diseases that can affect the level of vitamin D.
* Patients with physical limitations that would prohibit the participation in following exercise protocol.
* Participants consuming dietary supplements two months prior to the intervention.
* Participation in regular exercise during the past 6 months (2 days/week).
* Non cooperative patients and refused to continue the intervention program.
25 Years
35 Years
ALL
No
Sponsors
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Ziauddin University
OTHER
Responsible Party
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Erum Tanveer
PhD Scholar
Principal Investigators
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Erum Tanveer
Role: PRINCIPAL_INVESTIGATOR
Ziauddin University
Locations
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Ziauddin College of Physical Therapy
Karachi, Sindh, Pakistan
Countries
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References
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Other Identifiers
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86404243ETREH
Identifier Type: -
Identifier Source: org_study_id
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