Periodization Resistance Training on Quality of Life in Females With Hypothyroidism

Not Applicable

Recruiting

• Conditions: Hypothyroidism
• Interventions: Other: non linear periodization exercise; Other: linear periodization exercise; Drug: medical treatment

• Registration Number: NCT06757712
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2024-12-27
• Study Start: 2025-01-01
• Study First Posted: 2025-01-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-07-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Serum thyroid stimulating hormone (TSH) level	12 weeks	It will be measured by ELISA kits. This kit is an Enzyme Linked Immunosorbent Assay (ELISA). (Precheck bio, inc, @ EIA KIT, USA).
FreeT4 (thyroxine) level	12 weeks	It will be measured by ELISA kits. This kit is an Enzyme Linked Immunosorbent Assay (ELISA). (Precheck bio, inc, @ EIA KIT, USA).
FreeT3 (tri-iodothyronine) level	12 weeks	It will be measured by ELISA kits. This kit is an Enzyme Linked Immunosorbent Assay (ELISA). (Precheck bio, inc, @ EIA KIT, USA).
Health related Quality of life questionnaire	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Triglyceride-glucose (TyG) index	12 weeks	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\].
Quadriceps strength	12 weeks	It will be measured before and after treatment using a hand-held dynamometer (HHD), which offers a reliable and valid method.
Hand grip strength	12 weeks	It will be measured before and after treatment using a hand-held dynamometer (HHD), which offers a reliable and valid method.
9-item Fatigue Severity Scale (FSS)	12 weeks	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.

Trial Locations

Locations (1)

Suez University; 🇪🇬 Suez, Egypt