Periodization Resistance Training on Quality of Life in Females With Hypothyroidism

Nonlinear Versus Linear Periodized Resistance Training on Quality of Life in Females With Hypothyroidism

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

Study Overview

• Status: Recruiting
• Conditions: Hypothyroidism
• Intervention / Treatment: Other: non linear periodization exercise; Drug: medical treatment; Other: linear periodization exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mona Mahmoud Mohamed Abd Elhady, M.Sc; Phone Number: 01127744248; Email: dmonamahmoud925@gmail.com
• Study Contact Backup: Name: Salma Ibrahim AL Ghitany, PhD

Study Locations

• Egypt
  • Suez, Egypt
    • Recruiting
    • Suez University
    • Contact: Mona Mahmoud Mohamed Abd Elhady, M.Sc; Phone Number: 01127744248; Email: dmonamahmoud925@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Drug: medical treatment; The medical treatment will be received for 12 weeks.
Experimental: linear periodization exercise + medical treatment; It will consist of 25 females, who will receive linear periodization exercise in addition to their medical treatment.	Drug: medical treatment; The medical treatment will be received for 12 weeks.; 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.
Active Comparator: medical treatment; It will consist of 25 females, who will receive their medical treatment only.	Drug: medical treatment; The medical treatment will be received for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum thyroid stimulating hormone (TSH) level	It will be measured by ELISA kits. This kit is an Enzyme Linked Immunosorbent Assay (ELISA). (Precheck bio, inc, @ EIA KIT, USA).	12 weeks
FreeT4 (thyroxine) level	It will be measured by ELISA kits. This kit is an Enzyme Linked Immunosorbent Assay (ELISA). (Precheck bio, inc, @ EIA KIT, USA).	12 weeks
Health related Quality of life questionnaire	The Health related Quality of life will be assessed using short form 12 (SF-12), which uses only 12 questions to measure functional health and well being from the patient's perspective. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglyceride-glucose (TyG) index	The triglyceride-glucose (TyG) index indirectly assesses insulin resistance through a mathematical model that uses only laboratory data on fasting plasma triglyceride and glucose concentrations. The TyG index will be calculated according to the formula: fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL) /2].	12 weeks
Hand grip strength	It will be measured before and after treatment using a hand-held dynamometer (HHD), which offers a reliable and valid method.	12 weeks
9-item Fatigue Severity Scale (FSS)	It will be used before and after treatment to assess fatigue severity. The FFS is a nine-item unidimensional questionnaire scored on a seven-point Likert scale, with high sum scores indicating greater fatigue.	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Nesreen Gharib Mohamed Elnahas, PhD, Professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 15, 2025

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: December 27, 2024
• First Posted (Actual): January 3, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 7, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: P.T.REC/012/005442

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No