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Recruiting NCT07751445

Unilateral and Bilateral Resistance Training in Hypertension

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unilateral Resistance Training, Bilateral Resistance Training.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of the Effects of Unilateral and Bilateral Resistance Training on Heart Rate Variability, Muscle Strength, and Functional Capacity in Individuals With Hypertension: A Randomized Controlled Trial

Overview

Hypertension is associated with autonomic nervous system dysfunction, reduced muscle strength, and impaired functional capacity, all of which contribute to increased cardiovascular risk and decreased quality of life. Resistance training is recommended as a non-pharmacological intervention for hypertension; however, it remains unclear whether unilateral and bilateral resistance training produce different physiological adaptations, particularly regarding cardiac autonomic function. This randomized controlled trial aims to compare the effects of unilateral and bilateral resistance training on heart rate variability (HRV), muscle strength, and functional capacity in adults with hypertension. Eligible participants aged 40-75 years with a confirmed diagnosis of hypertension will be randomly allocated to one of three groups: a unilateral resistance training group, a bilateral resistance training group, or a control group. Randomization will be performed using a computer-generated block randomization procedure with sex stratification to ensure balanced group allocation. Participants in the two intervention groups will complete a supervised 12-week resistance training program, performed twice weekly at an intensity of 60-70% of one-repetition maximum (1RM). The unilateral training group will perform exercises using one limb at a time, whereas the bilateral training group will perform the same exercises simultaneously with both limbs. The control group will receive no structured exercise intervention during the study period but will receive general information regarding the benefits of physical activity. Assessments will be conducted at baseline and after the 12-week intervention. The primary outcome will be heart rate variability measured using a Polar H10 heart rate sensor and Elite HRV software. Secondary outcomes will include peripheral muscle strength assessed by one-repetition maximum testing, functional capacity assessed using the Six-Minute Walk Test and the Glittre Activities of Daily Living Test, and blood pressure measured using a sphygmomanometer. The findings of this study are expected to provide evidence regarding the optimal resistance training strategy for improving autonomic function and physical performance in individuals with hypertension, thereby supporting the development of safer and more individualized exercise prescriptions.

Detailed description

Hypertension is one of the leading modifiable risk factors for cardiovascular disease and is strongly associated with autonomic nervous system dysfunction. Increased sympathetic activity and reduced parasympathetic activity contribute to impaired cardiovascular regulation, which can be assessed non-invasively through heart rate variability (HRV). Reduced HRV has been associated with increased cardiovascular morbidity and mortality. In addition to autonomic dysfunction, individuals with hypertension frequently exhibit reduced muscle strength, impaired functional capacity, and limitations in daily physical activities.

Resistance training is widely recommended as a safe and effective non-pharmacological intervention for hypertension because it improves blood pressure control, muscular fitness, and overall physical function. Although both unilateral and bilateral resistance training are commonly prescribed, their physiological effects may differ. Unilateral resistance exercises generally involve a smaller active muscle mass, potentially resulting in lower cardiovascular stress while maintaining local muscular adaptations. In contrast, bilateral resistance exercises recruit a larger muscle mass and may induce greater cardiovascular and hemodynamic responses. Despite these theoretical differences, evidence directly comparing their effects on cardiac autonomic regulation in individuals with hypertension remains limited.

The primary objective of this randomized controlled trial is to compare the effects of unilateral and bilateral resistance training on cardiac autonomic function assessed by HRV in adults with hypertension. Secondary objectives include evaluating changes in peripheral muscle strength, functional capacity, activities of daily living, and blood pressure following a supervised resistance training program.

Adults aged 40 to 75 years with a physician-confirmed diagnosis of hypertension who are able to participate safely in resistance exercise will be recruited from Munzur University and Tunceli State Hospital. After providing written informed consent, eligible participants will be randomly assigned to one of three groups using a computer-generated block randomization procedure with sex stratification:

Unilateral Resistance Training Group Bilateral Resistance Training Group Control Group

Participants allocated to the intervention groups will complete a supervised 12-week resistance training program performed twice weekly. Exercise intensity will be prescribed at 60-70% of one-repetition maximum (1RM). Both intervention groups will perform the same resistance exercises, including leg press, knee extension, leg curl, seated row, and chest press. The unilateral group will perform each exercise separately with the right and left limbs, whereas the bilateral group will perform the exercises simultaneously using both limbs. Each exercise session will consist of 2-3 sets of 8-12 repetitions with at least one minute of rest between sets. Training loads will be progressively increased when participants are able to perform more than 20 repetitions with a perceived exertion below 3 on the Modified Borg Scale.

Participants in the control group will not receive supervised resistance training during the 12-week intervention period but will receive standardized education regarding the health benefits of regular physical activity. Following study completion, participants in the control group will be offered the exercise intervention if the training program is demonstrated to be beneficial.

Outcome assessments will be performed at baseline and after completion of the 12-week intervention. HRV will be measured using a Polar H10 heart rate sensor connected to the Elite HRV application. Measurements will be obtained before exercise, immediately after exercise, and during the recovery period. Time-domain variables, including RMSSD, SDNN, pNN50, and mean RR interval, as well as frequency-domain variables, including total power, LF power, HF power, LF/HF ratio, LF peak frequency, and HF peak frequency, will be analyzed.

Peripheral muscle strength will be evaluated using one-repetition maximum testing for leg press, knee extension, leg curl, seated row, and chest press. Functional capacity will be assessed using the Six-Minute Walk Test (6MWT), while functional performance in activities of daily living will be evaluated using the Glittre Activities of Daily Living Test (Glittre-ADL). Resting and exercise blood pressure will be measured using a validated sphygmomanometer.

The study hypothesis is that unilateral resistance training will produce improvements in HRV, muscle strength, and functional capacity comparable to or greater than bilateral resistance training while imposing lower cardiovascular stress. The findings are expected to provide evidence supporting individualized resistance exercise prescription for individuals with hypertension and contribute to the optimization of exercise-based cardiovascular rehabilitation programs.

Interventions

  • Other Unilateral Resistance Training
    Participants will complete a supervised unilateral resistance training program twice weekly for 12 weeks. Exercise intensity will be prescribed at 60-70% of one-repetition maximum (1RM). Exercises include leg press, knee extension, leg curl, seated row, and chest press performed separately with the right and left limbs. Each session consists of 2-3 sets of 8-12 repetitions with at least 1 minute of rest between sets. Training loads will be progressively increased based on participants' performan
  • Other Bilateral Resistance Training
    Participants will complete a supervised bilateral resistance training program twice weekly for 12 weeks. Exercise intensity will be prescribed at 60-70% of one-repetition maximum (1RM). Exercises include leg press, knee extension, leg curl, seated row, and chest press performed simultaneously with both limbs. Each session consists of 2-3 sets of 8-12 repetitions with at least 1 minute of rest between sets. Training loads will be progressively increased according to participants' performance and

Primary outcome measures

  • Muscle Strength [Time frame: Baseline and Week 12]
  • Functional Capacity [Time frame: Baseline and Week 12]
  • RMSSD [Time frame: Baseline and Week 12]
  • SDNN [Time frame: Baseline and Week 12]
  • pNN50 [Time frame: Baseline and Week 12]
  • Mean RR Interval [Time frame: Baseline and Week 12]
  • Total Power [Time frame: Baseline and Week 12]
  • LF Power [Time frame: Baseline and Week 12]
  • HF Power [Time frame: Baseline and Week 12]
  • LF Peak [Time frame: Baseline and Week 12]
Secondary outcome measures (2)
  • Activities of Daily Living [Time frame: Baseline and Week 12]
  • Blood Pressure [Time frame: Baseline and Week 12]

Eligibility criteria

Inclusion criteria

  • Adults aged 40 to 75 years.
  • Physician-confirmed diagnosis of hypertension.
  • Medically stable and able to safely participate in a supervised resistance training program.
  • Able to understand the study procedures and provide written informed consent.

Exclusion criteria

  • Presence of cardiovascular diseases other than hypertension.
  • Neurological disorders.
  • Psychiatric disorders.
  • Orthopedic conditions limiting participation in resistance exercise.
  • Any other systemic disease that may interfere with study participation.
  • Cognitive impairment or psychological conditions preventing completion of the assessments.
  • History of recent surgery or medical conditions contraindicating exercise.
  • Inability or unwillingness to comply with the study protocol.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Munzur University Faculty of Health Sciences — Tunceli

Publications

  • Khoury M, Cordina R. Exercise Training for People Living With Fontan Circulation: An Underutilized Intervention. Can J Cardiol. 2022 Jul;38(7):1012-1023. doi: 10.1016/j.cjca.2022.01.008. Epub 2022 Jan 15. PMID 35041931

Identifiers

NCT: NCT07751445 · 2026/8-21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗