Periodization Resistance Training on Quality of Life in Females With Hypothyroidism

NCT ID: NCT06757712

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-10-15

Brief Summary

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This study will be conducted to compare between the effect of nonlinear and linear periodized training on quality of life in females with hypothyroidism.

Detailed Description

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Worldwide, the incidence of individuals with thyroid dysfunction is increasing and represents approximately 30-40% of the patients seen in an endocrine clinic; thus, it is one of the leading endocrine disorders.The undiagnosed thyroid dysfunction especially subclinical and clinical hypothyroidism may increase cardiovascular risk factors.

The prevalence of hypothyroidism depends on many factors, such as age, sex and geographical factors. It's also a diet related disorder and it's usually seen when the daily intake of iodine falls below 25μg.

Hypothyroidism tends to affect women more often than men and can manifest at any age, typically observed between 40 and 70 years. No specific racial predilection has been identified in studies regarding this condition. regular exercise can improve quality of life in patients with subclinical hypothyroidism by increasing physical activity level/fitness and reducing the signs and symptoms of the disease. Exercise may therefore potentiate the effectiveness of levothyroxine and help hypothyroid individuals improve their quality of life.

Periodization of resistance training or planned changes in training volume and intensity are used to maximize strength and fitness gains. The most common of periodized resistance training plans is linear also termed classic or strength/power periodization and nonlinear periodization. The biggest difference between these two types of training plans is with nonlinear periodization changes in training volume and intensity are made more frequently. The most common type of nonlinear periodization is daily nonlinear periodization where substantial changes in training intensity and volume are made from one training session to the next training session.

So, this study will be conducted to compare between the effect of non linear and linear periodized resistance training on quality of life in females with hypothyroidism.

Conditions

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Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non linear periodization exercise + medical treatment

It will consist of 25 females, who will receive non linear periodization exercise in addition to their medical treatment.

Group Type EXPERIMENTAL

non linear periodization exercise

Intervention Type OTHER

The non-linear periodized resistance training program follows a 12-week schedule with varying intensity levels across three training days per week. The intensity fluctuates between very light (VL), light (L), moderate (M), heavy (H), and very heavy (VH) workouts, distributed strategically throughout the week. Each training day implements different intensity levels, and an active rest day follows any workout session.

medical treatment

Intervention Type DRUG

The medical treatment will be received for 12 weeks.

linear periodization exercise + medical treatment

It will consist of 25 females, who will receive linear periodization exercise in addition to their medical treatment.

Group Type EXPERIMENTAL

linear periodization exercise

Intervention Type OTHER

The linear periodization exercise program spans 12 weeks with systematically varied training parameters. During weeks 1-2, participants perform 3 sets of 10 repetitions, followed by 3 sets of 8 repetitions in weeks 3-4. The program progresses to 4 sets of 6 repetitions in weeks 5-6, then 3 sets of 6 repetitions during weeks 7-8. The final phases consist of 4 sets of 4 repetitions in weeks 9-10, concluding with 3 sets of 4 repetitions in weeks 11-12. Training loads advance through autoregulatory progression, where participants progress at their individual pace under supervision. While sets and repetitions remain fixed within each phase, load progression is determined by performance in the final set of each exercise, ensuring safe and effective advancement.

medical treatment

Intervention Type DRUG

The medical treatment will be received for 12 weeks.

medical treatment

It will consist of 25 females, who will receive their medical treatment only.

Group Type ACTIVE_COMPARATOR

medical treatment

Intervention Type DRUG

The medical treatment will be received for 12 weeks.

Interventions

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non linear periodization exercise

The non-linear periodized resistance training program follows a 12-week schedule with varying intensity levels across three training days per week. The intensity fluctuates between very light (VL), light (L), moderate (M), heavy (H), and very heavy (VH) workouts, distributed strategically throughout the week. Each training day implements different intensity levels, and an active rest day follows any workout session.

Intervention Type OTHER

linear periodization exercise

The linear periodization exercise program spans 12 weeks with systematically varied training parameters. During weeks 1-2, participants perform 3 sets of 10 repetitions, followed by 3 sets of 8 repetitions in weeks 3-4. The program progresses to 4 sets of 6 repetitions in weeks 5-6, then 3 sets of 6 repetitions during weeks 7-8. The final phases consist of 4 sets of 4 repetitions in weeks 9-10, concluding with 3 sets of 4 repetitions in weeks 11-12. Training loads advance through autoregulatory progression, where participants progress at their individual pace under supervision. While sets and repetitions remain fixed within each phase, load progression is determined by performance in the final set of each exercise, ensuring safe and effective advancement.

Intervention Type OTHER

medical treatment

The medical treatment will be received for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be controlled hypothyroidism (TSH level within 0.5 - 4.5 mU/L)
* Be ranged from 35 to 45 years
* Female patients
* Body Mass Index 30-34.9 kg/m2 .
* triglyceride-glucose (TyG) index \> 4.5

Exclusion Criteria

* history of pulmonary disease
* Patients with uncontrolled coronary or cerebrovascular disease
* Those who underwent musculoskeletal surgery within the previous year
* Recent history of lower and upper limb fracture , hip and shoulder dislocation.
* Cognitive impaired patients
* Patients with history of epilepsy
* Patients who participating in any other exercise program
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mona Mahmoud Mohamed Abd elhady

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nesreen Gharib Mohamed Elnahas, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Locations

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Suez University

Suez, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mona Mahmoud Mohamed Abd Elhady, M.Sc

Role: CONTACT

01127744248

Salma Ibrahim Al Ghitany, PhD

Role: CONTACT

Facility Contacts

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Mona Mahmoud Mohamed Abd Elhady, M.Sc

Role: primary

01127744248

Other Identifiers

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P.T.REC/012/005442

Identifier Type: -

Identifier Source: org_study_id

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