NCT06757712

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

December 27, 2024

Last Update Submit

September 7, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Triglyceride-glucose (TyG) index

    12 weeks

  • Hand grip strength

    12 weeks

  • 9-item Fatigue Severity Scale (FSS)

    12 weeks

Study Arms (3)

non linear periodization exercise + medical treatment

EXPERIMENTAL

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

Other: non linear periodization exerciseDrug: medical treatment

linear periodization exercise + medical treatment

EXPERIMENTAL

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

Other: linear periodization exerciseDrug: medical treatment

medical treatment

ACTIVE COMPARATOR

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

Drug: medical treatment

Interventions

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.

non linear periodization exercise + medical treatment

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.

linear periodization exercise + medical treatment

The medical treatment will be received for 12 weeks.

linear periodization exercise + medical treatmentmedical treatmentnon linear periodization exercise + medical treatment

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez University

Suez, Egypt

RECRUITING

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Nesreen Gharib Mohamed Elnahas, PhD

    Professor, Cairo university

    STUDY CHAIR

Central Study Contacts

Mona Mahmoud Mohamed Abd Elhady, M.Sc

CONTACT

Salma Ibrahim Al Ghitany, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 3, 2025

Study Start

January 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 15, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations