IRCT | Effectiveness of lower limb strength training and aerobic exercises in combination with lifestyle modification on strength, aerobic fitness and quality of life in patients with type II diabetes mellitus.

Protocol summary

Study aim: To evaluate the effectiveness of lower limb strength training and aerobic exercises in combination with lifestyle modification on strength, aerobic fitness and quality of life in patients with type II diabetes
Design: Parallel group randomized clinical trial and Randomization will be achieved through computer generated random allocation software.
Settings and conduct: District Head Quarter (DHQ) teaching Hospital Faisalabad, Tehsil Headquarter Hospital Gojra, AL Barkat Hospital Gojra, Hajra Tufail Hospital, Gojra. Patients and outcome assessor will be blinded. It will be assessor and participant who will be blinded about the type of intervention. Treatment will be given by principal /investigator.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Both male and female patients, Age: 40 to 60 years, Patient with diabetes type II diagnosed by physician Exclusion criteria: Unsafe blood pressure, Mental retardation, Any recent surgery (cardiac, musculoskeletal and neurological) ,Fracture ,Limb amputation and joint replacement ,Central nervous system dysfunction (stroke, Parkinson disease)
Intervention groups: The intervention group will include lower limb strength training, aerobic exercises, and a lifestyle modification program. Session duration will be 45 minutes, thrice a week, and 24 sessions over 8 weeks. The interventions of the control group will include lower limb strength training, aerobic exercises, and unguided lifestyle instructions. Session duration will be 45 minutes, thrice a week and 24 sessions over 8 weeks.
Main outcome variables: Strength, Aerobic fitness, Quality of life

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20230216057434N7

Registration date: 2024-03-10, 1402/12/20

Registration timing: prospective

Last update: 2024-03-10, 1402/12/20

Update count: 0
Registration date: 2024-03-10, 1402/12/20

Registrant information: Name

Zainab Sheraz

Name of organization / entity

Riphah International University, Faisalabad

Country

Pakistan

Phone

+92 301 7070941

Email address

zainab.48@hotmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-03-15, 1402/12/25
Expected recruitment end date: 2024-05-22, 1403/03/02
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effectiveness of lower limb strength training and aerobic exercises in combination with lifestyle modification on strength, aerobic fitness and quality of life in patients with type II diabetes mellitus.

Public title: Effects of lower limb strength training and aerobic exercise in combination with lifestyle modification in type II diabetes mellitus.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Both male and female patients Age: 40 to 60 years Patient with diabetes type II diagnosed by physician

Exclusion criteria:

Unsafe blood pressure Mental retardation Any recent surgery (cardiac, musculoskeletal and neurological) Fracture Limb amputation and joint replacement Central nervous system dysfunction (stroke, Parkinson disease)
Age: From 40 years old to 60 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Outcome assessor

Sample size

Target sample size: 54

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization will be done through a computer software "Random allocation software Version 2. The total sample size will be entered with required number of participants to be allocated in two groups. An automated randomization list will be achieved with attrition rate included. The program starts running with the default settings. Users may run the program with the default settings or set the number of groups, the name of participants in each group and the sample size. Clicking the 'Generate' button produces the random sequence. Before generating the random sequence, the option window will be displayed and different randomization settings can be entered.

Blinding (investigator's opinion)

Double blinded

Blinding description

Blinding will be done on part of outcome assessor who will be an experienced therapist. Patients will be assessed by him at the end of treatment session. He will be blinded about the type of intervention patient will receive. Patients will also be blinded about the type of intervention they will received.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Riphah International University Faisalabad

Street address

Riphah International University, Faisalabad

City

Faisalabad

Postal code

38000
Approval date: 2024-03-01, 1402/12/11
Ethics committee reference number: RCRAHS/REC/24/9

Health conditions studied

1

Description of health condition studied: Diabetes mellitus II
ICD-10 code: E11. 9
ICD-10 code description: Diabetes mellitus II

Primary outcomes

1

Description: Strength
Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 8 weeks treatment.
Method of measurement: Five times sit to stand test

Secondary outcomes

1

Description: Aerobic fitness
Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 8 weeks treatment.
Method of measurement: Harvard step test

2

Description: Quality of life
Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 8 weeks treatment.
Method of measurement: SF-36

Intervention groups

1

Description: Group A (Intervention group) consisting of 27 patients will receive an exercise session of 3 minutes warm-up that includes walking at a slow pace, followed by lower limb strength training and aerobic exercise. In the intervention group, patients will receive lower limb strength training in the form of resistance exercises which will consist of hip abduction/adduction with a sandbag worn on the ankle, step (hip and knee flexion/extension), and tiptoe (ankle flexion/extension) with sandbag worn on the ankle. Patients will perform these exercises in standing position with the assistance of a chair. For the 1st four weeks, the sandbag weighing 0.5 kg will be worn with each exercise and performed for 8-15 times. After 4 weeks, the weight of the sandbag will progress to 1kg till 8th week. The total time for lower limb strength training exercises will be 20 minutes. Aerobic exercises will consist of 10 minutes of stationary cycling and 10 minutes of step-ups. The patients will be instructed while doing step-ups, they will keep their back straight. The total time for aerobic exercises would be 20 minutes, followed by 2 minutes of cool-down exercises which will consist of breathing exercises. The total session duration for the Intervention group will be 45 minutes and will repeat thrice a week, 24 sessions over 8 weeks. Lifestyle modification program which will include: Mediterranean diet instructions like consumption of fruit and vegetables (one or two portions a day), whole grains, legumes, and nuts it will also include a moderate quantity of fish and dairy products while minimizing the intake of meat, processed and industrial food. Healthy sleep instructions according to the guidelines developed by the American Academy of Sleep Medicine includes: setting a bedtime that is early enough for a person to get at least 7-8 hours of sleep, making your bedroom quiet and relaxing before sleeping, limiting exposure to bright light in the evening, turning off electronic devices at least 30 minutes before bedtime, don’t eat a large meal before bedtime, avoiding consuming caffeine in the afternoon or evening
Category: Treatment - Other

2

Description: Group B (Control Group) consisting of 27 patients will receive an exercise session of 3 minutes warm-up that will include walking at a slow pace, followed by lower limb strength training and aerobic exercise. Lower limb strength training in the form of resistance exercises which will consist of hip abduction/adduction with a sandbag worn on the ankle, step (hip and knee flexion/extension), and tiptoe (ankle flexion/extension) with sandbag worn on the ankle. The patient will perform these exercises in a standing position with the assistance of a chair. For the 1st four weeks sandbag weighing 0.5 kg will be worn with each exercise and performed for 8-15 times. After 4 weeks, the weight of the sandbag will be progressed to 1kg till 8th weeks. The total time for lower limb strength training exercises will be 20 minutes. Aerobic exercises will consist of 10 minutes of stationary cycling and 10 minutes of step-ups. The Patients will be instructed while doing step-ups, they will keep their back straight. The total time for aerobic exercises would be 20 minutes, followed by 2 minutes of cool-down exercises which consist of breathing exercises. In unguided lifestyle instructions, the therapist will advise the patient to live a healthy life and eat a healthy diet without specific or detailed guidance or instructions. The total session duration for the Control group will be 45 minutes and will repeat thrice a week, 24 sessions over 8 weeks.
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

District Headquarter Hospital, Faisalabad

Full name of responsible person

Maria Irshad

Street address

Mall Road, near Faisalabad Railway Station

City

Faisalabad

Postal code

38000

Phone

+92 302 7935249

Email

mariairshad098@gmail.com

2

Recruitment center: Name of recruitment center

Tehsil Headquarter Hospital, Gojra

Full name of responsible person

Anam Sabir

Street address

Jhang Road, Gojra

City

Gojra

Postal code

56000

Phone

+92 306 8835013

Email

anamsabirpml58@gmail.com

3

Recruitment center: Name of recruitment center

Hajra Tufail Hospital, Gojra

Full name of responsible person

Khadeeja

Street address

Mongi Bangla Road, Gojra, Toba Tek Singh District

City

Gojra

Postal code

56000

Phone

+92 305 9880245

Email

ah8490184@gmail.com

4

Recruitment center: Name of recruitment center

Al Barkat Hospital, Gojra

Full name of responsible person

Aqsa

Street address

Faisalabad Road, Gojra, Toba Tek Singh District, Punjab

City

Gojra

Postal code

56000

Phone

+92 304 5514364

Email

ma0176589@gmail.com

Web page address

1

Sponsor: Name of organization / entity

Self Funded

Full name of responsible person

Zainab Sheraz

Street address

House no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad

City

Faisalabad

Postal code

38000

Phone

+92 335 6600141

Email

zainab.48@hotmail.com

Web page address

https://www.riphahfsd.edu.pk/
Grant name: N/A
Grant code / Reference number: N/A
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: N/A
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

Riphah International University, Faisalabad

Full name of responsible person

Zainab Sheraz

Position

Assistant Professor

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

House no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad

City

Faisalabad

Province

Punjab

Postal code

38000

Phone

+92 335 6600141

Email

zainab.48@hotmail.com

Web page address

https://www.riphahfsd.edu.pk/

Person responsible for scientific inquiries

Contact: Name of organization / entity

Riphah International University, Faisalabad

Full name of responsible person

Zainab Sheraz

Position

Assistant Professor

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

House no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad

City

Faisalabad

Province

Punjab

Postal code

38000

Phone

+92 335 6600141

Email

zainab.48@hotmail.com

Web page address

https://www.riphahfsd.edu.pk/

Person responsible for updating data

Contact: Name of organization / entity

Riphah International University, Faisalabad

Full name of responsible person

Zainab Sheraz

Position

Assistant Professor

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

House no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad

City

Faisalabad

Province

Punjab

Postal code

38000

Phone

+92 335 6600141

Email

zainab.48@hotmail.com

Web page address

https://www.riphahfsd.edu.pk/

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: Real patient is involved
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: No - There is not a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available

Effectiveness of lower limb strength training and aerobic exercises in combination with lifestyle modification on strength, aerobic fitness and quality of life in patients with type II diabetes mellitus.