Protocol summary
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Study aim
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The aim of the study is to evaluates the effects of resistance training versus endurance training on hyperlipidemia, uric acid, and glucose levels in patients with metabolic syndrome
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Design
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Parallel, 64 sample size, Randomized Clinical Trial, single blinded
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Settings and conduct
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The trial will be conducted in the Physiotherapy department of Punjab Social Security Health Management Company Hospital and sharif city polyclinic raiwind. The assessor will be completely blind to outcomes
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
Age 30-50 years individuals,
Male and female both,
Having Metabolic syndrome 22
Exclusion Criteria:
Type I diabetes,
Heart failure,
Renal problems,
Mal absorption syndrome,
History of bariatric surgery,
Participants who were taking weight loss medications,
Smoker, alcohol intake,
Pregnant or lactation22
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Intervention groups
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The participant will be divided into two groups. Both groups will follow two different supervised exercise training programs.
Group A follows Endurance exercises: 30 min per day of endurance exercise training on the treadmill, intensity will be adjusted through HRmax(heart rate maximum) .
Group B follows Resistance exercises: exercise starts with 30% repetition maximum of resistance exercise training on multiple exercise units, 3 sets of 9 exercises, six times per week with 10 repetitions, 1 min rest between sets. The load will be adjusted every week according to the 70% 1RM rule.
9 resistance exercises that will be followed during 12 weeks on multiple exercise units are listed below
1. Front raises
2. Shoulder shrug
3. Bicep curl
4. Seated dumbbell press
5. Lateral raises
6. Pull down
7. Leg extension curl
8. Seated row
9. Chest press
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Main outcome variables
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blood pressure, sugar level( HBA1C), lipid profile(triglyceride, high and low density lipid), uric acid levels, pain
General information
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Reason for update
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I made some minor mistakes when registering the trial last time.trial completed
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Acronym
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RCT
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IRCT registration information
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IRCT registration number:
IRCT20210704051785N2
Registration date:
2022-09-26, 1401/07/04
Registration timing:
registered_while_recruiting
Last update:
2023-07-23, 1402/05/01
Update count:
1
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Registration date
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2022-09-26, 1401/07/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-09-01, 1401/06/10
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Expected recruitment end date
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2022-12-30, 1401/10/09
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Actual recruitment start date
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2022-09-01, 1401/06/10
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Actual recruitment end date
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2022-12-30, 1401/10/09
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Trial completion date
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2023-04-01, 1402/01/12
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Scientific title
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Effects of Resistance Training Versus Endurance Training on Hyperlipidemia, Uric Acid and Glucose levels In Patients with Metabolic Syndrome: a randomized clinical trial
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Public title
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which exercise can reduce blood pressure, sugar and joint pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
having metabolic syndrome according to ATP III CRITERIA
Both gender age 30 to 50 years
Exclusion criteria:
Type I diabetes
Heart failure
Renal problems
Mal-absorption syndrome
History of bariarrtic surgery
Participants who were taking weight loss medications
Smoker,
alcohol intake
Pregnant or lactation
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Age
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From 30 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
64
Actual sample size reached:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Sealed envelope method will be used for random allocation. 64 sealed envelopes (32 for Group A and 32 for Group B) will be prepared. 32 envelopes will contain letter A, 32 envelopes will contain letter B on a card. Patient will be asked to choose one envelope. Treatment will be given according to treatment group (Group A: control, Group B: experiment).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Senior physiotherapist will assess patient before and after treatment. Senior physiotherapist/assessor will be completely blinded about patient allocation group (control/intervention).
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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no
Ethics committees
1
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Ethics committee
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Approval date
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2022-09-01, 1401/06/10
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Ethics committee reference number
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SMDC/SMRC/ 258-22
Health conditions studied
1
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Description of health condition studied
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metabolic syndrome
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ICD-10 code
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E88.81
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ICD-10 code description
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Metabolic syndrome
2
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Description of health condition studied
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hyperlipidemia
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ICD-10 code
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E78.4
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ICD-10 code description
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Other hyperlipidemia
3
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Description of health condition studied
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diabetes
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ICD-10 code
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E08
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ICD-10 code description
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Diabetes mellitus due to underlying condition
Primary outcomes
1
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Description
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Hyperlipidemia
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Timepoint
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hyperlipidemia will be measured before and after 12 weeks of treatment.
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Method of measurement
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hyperlipidemia will be measured through laboratory blood test.
2
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Description
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sugar levels
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Timepoint
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sugar levels will be measured before and after 12 weeks of treatment.
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Method of measurement
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sugar levels will be measured through laboratory blood test.
3
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Description
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uric acid
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Timepoint
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uric acid will be measured before and after 12 weeks of treatment.
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Method of measurement
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uric acid will be measured through laboratory blood test.
4
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Description
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waist circumference
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Timepoint
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waist circumference will be measured before and after 12 weeks of treatment.
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Method of measurement
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waist circumference will be measured with measuring tape.
5
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Description
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blood pressure
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Timepoint
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blood pressure will be measured before and after 12 weeks of treatment.
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Method of measurement
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blood pressure will be measured through mercury blood pressure apparatus.
Secondary outcomes
1
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Description
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pain
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Timepoint
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pain will be measured before and after 12 weeks of treatment.
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Method of measurement
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pain will be measured through visual analogue scale.
2
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Description
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body mass index
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Timepoint
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body mass index will be measured before and after 12 weeks of treatment.
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Method of measurement
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body mass index will be measured by measuring height and weight of individual.
3
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Description
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VO2MAX
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Timepoint
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vo2max will be measured before and after 12 weeks of treatment.
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Method of measurement
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vo2max will be measured by rockport walking fitness test.
Intervention groups
1
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Description
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Intervention group: follows Resistance exercises( 6 days a week ): exercise starts with 30% repetition maximum of resistance exercise training on multiple exercise units, 3 sets of 9 exercises, six times per week with 10 repetitions, 1 min rest between sets. The load will be adjusted every month according to the 70% 1RM rule.9 resistance exercises that will be followed during 12 weeks on multiple exercise units are listed below1. Front raises2. Shoulder shrug3. Bicep curl4. Seated dumbbell press5. Lateral raises6. Pull down7. Leg extension curl8. Seated row9. Chest press23
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Category
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Treatment - Other
2
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Description
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control group: Endurance exercises: 30 min per day( 6 days a week ) of endurance exercise training on the treadmill, intensity will be adjusted through HRmax.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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sarwat anees
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available