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Completed

NCT Number: NCT06145243

Comparison of the Effectiveness of Supervised, Video-based and Home-based Resistance Exercise Program in Patients With Prostate Cancer

The aim of this study was to compare the effects of video-based application method of resistance exercise training and supervised exercise training on mobility, body composition, quality of life, fatigue, muscle strength and physical performance in patients with prostate cancer receiving androgen deprivation therapy treatment.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

65 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Professor Cemil Taşcıoğlu Training and Research Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with prostate cancer with at least 1 year of Androgen deprivation therapy treatment
  • 65 years of age or older
  • No speech and hearing problems

Exclusion criteria

  • Presence of metastatic cancer focus
  • Carrying a pacemaker
  • Mental and coordination problems
  • Patients with neurological or orthopedic pathology that would prevent participation in exercise

Treatment and study plan

Home based exercise

Other

Patients will be given a visual brochure with pictures explaining the exercises. Patients will perform the resistance exercises in the given exercise program for 8 weeks, 2 days a week for 8-12 repetitions and 3 sets using resistance bands.Progress of the home exercise group will be checked by phone every week.

Video-based resistive exercise

Other

A video recording of the exercises will be taken and given to the patients as a video recording.Patients will perform the resistance exercises in the given exercise program for 8 weeks, 2 days a week for 8-12 repetitions and 3 sets using resistance bands.Progress of the video-based exercise group will be checked by phone every week.

Supervised resistive exercise

Other

Patients will perform their exercises under the supervision of a physiotherapist.Patients will perform the resistance exercises in the given exercise program for 8 weeks, 2 days a week for 8-12 repetitions and 3 sets using resistance bands.

Primary outcomes

  1. Muscle strength

    Time frame: 8 weeks

    Muscle strength of the patients' reference muscles gluteus maximus, quadriceps, hamstring, gastrocsoleus, gluteus medius, will be evaluated with Hand Held dynamometer.For each muscle group, 3 measurements will be made at 1 minute intervals and the average of the measurements will be accepted as the evaluation result.

  2. Body composition- fat percentage

    Time frame: 8 weeks

    Total body fat percentage, will be measured using Dual-Energy Xray Absorptiometry (DEXA) at baseline and after treatment in percentile.

  3. Body composition- Body mass index( BMI in kg/m^2)

    Time frame: 8 weeks

    Total body fat mass, will be measured using Dual-Energy Xray Absorptiometry (DEXA) at baseline and after treatment in BMI in kg/m^2.

  4. Short Physical Performance Battery

    Time frame: 8 weeks

    The physical performance level of the patients will be assessed with the short physical performance battery, which is a combined test that includes a chair stand test along with gait speed and balance assessment. The maximum score is 12 and a score of ≤8 indicates poor physical performance.

  5. Quality of Life- Functional Assessment of Cancer Therapy - Prostate cancer (FACT-P)

    Time frame: 8 weeks

    FACT-P is a scale that assesses the quality of life of patients with prostate cancer. The 27-question general version consists of sections assessing emotional, social or family, physical and functional status. There are 12 questions about the treatment of patients with prostate cancer and additional concerns. The lowest score is 0 and the highest score is 156. A high score indicates good quality of life.

Secondary outcomes

  1. Grip strength

    Time frame: 8 weeks

    Grip strength was evaluated by hand grip dynamometry. Measurements were performed in affected side according to positions defined by American Society of Hand Therapists (sitting with the shoulder adducted to the side and the elbow flexed 90° with the forearm and wrist in the neutral mid-position)

  2. Fatigue -Functional assessment of chronic illness therapy - fatigue

    Time frame: 8 weeks

    FACIT-F consists of 13 questions assessing the level of fatigue during daily activities in the last week. The maximum score is 52. A high score indicates a high level of fatigue. It is a Likert-type scale scored between 0-4.

  3. Sarcopenia Risk Survey

    Time frame: 8 weeks

    Sarcopenia Risk Survey is a 5-item questionnaire self-reported by patients as a screening for sarcopenia risk. It assesses 5 components: strength, supported walking, getting up from a chair, climbing stairs and falling. Scoring for each component ranges from 0-2, with a total score of 0-10. A score of 4 or more indicates sarcopenia.

  4. Anxiety - The Hospital Anxiety and Depression Scale (HADS)

    Time frame: 8 weeks

    The Hospital Anxiety and Depression Scale (HADS) Anxiety and depression levels of the patients will be evaluated with the HADS questionnaire.This scale has subscales for anxiety and depression. It includes a total of 14 questions. Seven items measure anxiety and the other seven items measure depression. The lowest score is "0" and the highest score is "21". An increase in the total score indicates an increase in the level of anxiety and depression.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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