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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General information
RCT
RCT
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64
64
2022-09-30, 1401/07/08
2022-12-30, 1401/10/09
2022-0912-30 00:00:00
empty
2022-09-01, 1401/06/10
2022-09-01 00:00:00
empty
2022-12-30, 1401/10/09
2022-12-30 00:00:00
empty
2023-04-01, 1402/01/12
2023-04-01 00:00:00
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I made some minor mistakes when registering the trial last time.trial completed
I made some minor mistakes when registering the trial last time.trial completed
Effects of Resistance Training Versus Endurance Training on Hyperlipidemia, Uric Acid and Glucose levels In Patients with Metabolic SyndromeEffects of Resistance Training Versus Endurance Training on Hyperlipidemia, Uric Acid and Glucose levels In Patients with Metabolic Syndrome: a randomized clinical trial
Effects of Resistance Training Versus Endurance Training on Hyperlipidemia, Uric Acid and Glucose levels In Patients with Metabolic Syndrome: a randomized clinical trial
Effects of Resistance Training Versus Endurance Training on Hyperlipidemia, Uric Acid and Glucose levels In Patients with Metabolic SyndromeEffects of Resistance Training Versus Endurance Training on Hyperlipidemia, Uric Acid and Glucose levels In Patients with Metabolic Syndrome: a randomized clinical trial
Ethics committees
#1
SMDC/SMRC/ 358-22
SMDC/SMRC/ 258-22
SMDC/SMRC/ 358258-22
Secondary outcomes
#1
empty
VO2MAX
VO2MAX
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vo2max will be measured before and after 12 weeks of treatment.
vo2max will be measured before and after 12 weeks of treatment.
empty
vo2max will be measured by rockport walking fitness test.
vo2max will be measured by rockport walking fitness test.
Protocol summary
Study aim
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
Design
Parallel, 64 sample size, Randomized Clinical Trial, single blinded
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
blood pressure, sugar level( HBA1C), lipid profile(triglyceride, high and low density lipid), uric acid levels, pain
General information
Reason for update
I made some minor mistakes when registering the trial last time.trial completed
Acronym
RCT
IRCT registration information
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
Registration date
2022-09-26, 1401/07/04
Registrant information
Name
Sarwat Anees
Name of organization / entity
Sharif medical and dental college
Country
Pakistan
Phone
+92 42 35397101
Email address
sarwatasifmehmood@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-01, 1401/06/10
Expected recruitment end date
2022-12-30, 1401/10/09
Actual recruitment start date
2022-09-01, 1401/06/10
Actual recruitment end date
2022-12-30, 1401/10/09
Trial completion date
2023-04-01, 1402/01/12
Scientific title
Effects of Resistance Training Versus Endurance Training on Hyperlipidemia, Uric Acid and Glucose levels In Patients with Metabolic Syndrome: a randomized clinical trial
Public title
which exercise can reduce blood pressure, sugar and joint pain
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
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).
Blinding (investigator's opinion)
Single blinded
Blinding description
Senior physiotherapist will assess patient before and after treatment. Senior physiotherapist/assessor will be completely blinded about patient allocation group (control/intervention).
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of sharif medical and dental college lahore
Street address
Sharif polyclinic, near doce bakers, railway road raiwind
City
Lahore
Postal code
55150
Approval date
2022-09-01, 1401/06/10
Ethics committee reference number
SMDC/SMRC/ 258-22
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
2
Description of health condition studied
hyperlipidemia
ICD-10 code
E78.4
ICD-10 code description
Other hyperlipidemia
3
Description of health condition studied
diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Hyperlipidemia
Timepoint
hyperlipidemia will be measured before and after 12 weeks of treatment.
Method of measurement
hyperlipidemia will be measured through laboratory blood test.
2
Description
sugar levels
Timepoint
sugar levels will be measured before and after 12 weeks of treatment.
Method of measurement
sugar levels will be measured through laboratory blood test.
3
Description
uric acid
Timepoint
uric acid will be measured before and after 12 weeks of treatment.
Method of measurement
uric acid will be measured through laboratory blood test.
4
Description
waist circumference
Timepoint
waist circumference will be measured before and after 12 weeks of treatment.
Method of measurement
waist circumference will be measured with measuring tape.
5
Description
blood pressure
Timepoint
blood pressure will be measured before and after 12 weeks of treatment.
Method of measurement
blood pressure will be measured through mercury blood pressure apparatus.
Secondary outcomes
1
Description
pain
Timepoint
pain will be measured before and after 12 weeks of treatment.
Method of measurement
pain will be measured through visual analogue scale.
2
Description
body mass index
Timepoint
body mass index will be measured before and after 12 weeks of treatment.
Method of measurement
body mass index will be measured by measuring height and weight of individual.
3
Description
VO2MAX
Timepoint
vo2max will be measured before and after 12 weeks of treatment.
Method of measurement
vo2max will be measured by rockport walking fitness test.
Intervention groups
1
Description
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
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Punjab Social Security Health Management Company Hospital, Raiwind, Lahore
Full name of responsible person
Sarwat Anees
Street address
Sharif polyclinic, near doce bakers, railway road, raiwind
City
Raiwind
Postal code
55150
Phone
+92 303 4846498
Email
sarwataneesphysio@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
sharif medical city polyclinic, raiwind.
Full name of responsible person
Sarwat Anees
Street address
Sharif polyclinic, near doce bakers, railway road, raiwind
City
Raiwind
Postal code
55150
Phone
+92 303 4846498
Fax
+92 42 37860122
Email
sarwataneesphysio@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
sharif medical and dental college
Full name of responsible person
Sarwat Anees
Street address
Sharif polyclinic, near doce bakers, railway road, raiwind
City
Raiwind
Postal code
55150
Phone
+92 303 4846498
Fax
+92 42 37860122
Email
sarwatasifmehmood@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
sarwat anees
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Sharif Medical and Dental College
Full name of responsible person
Fozia Butt
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Sharif polyclinic, near doce bakers, railway road raiwind, Sharif polyclinic
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 42 86586523
Fax
+92 42 37860122
Email
sarwatasifmehmood@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Punjab Social Security Health Management Company Hospital
Full name of responsible person
Sarwat Anees
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sharif Polyclinic, near Doce Bakers, Railway Road, Raiwind
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 303 4846498
Email
sarwatasifmehmood@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Punjab Social Security Health Management Company Hospital
Full name of responsible person
Sarwat Anees
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sharif Polyclinic, near Doce Bakers, Railway Road, Raiwind
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 303 4846498
Email
sarwatasifmehmood@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available