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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145243
• Other study ID #: ATADEK 2023-10/342
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Acibadem University
• Contact: Özlem Feyzioglu, PhD
• Phone: 05353529794
• Email: fztozlemfeyzioglu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Home based exercise
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
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
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.

Locations

Country	Name	City	State
Turkey	Professor Cemil Tascioglu Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength	Muscle strength of the patients' reference muscles gluteus maximus, quadriceps, hamstring, gastrocsoleus, gluteus medius, shoulder abduction, biceps, triceps, shoulder flexion 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.	8 weeks
Primary	Body composition- total body mass	Total body fat mass, will be measured using Dual-Energy Xray Absorptiometry (DEXA) at baseline and after treatment in kilograms.	8 weeks
Primary	Body composition- fat percentage	Total body fat percentage, will be measured using Dual-Energy Xray Absorptiometry (DEXA) at baseline and after treatment in percentile.	8 weeks
Primary	Body composition- Body mass index( BMI in kg/m^2)	Total body fat mass, will be measured using Dual-Energy Xray Absorptiometry (DEXA) at baseline and after treatment in BMI in kg/m^2.	8 weeks
Primary	Short Physical Performance Battery	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.	8 weeks
Primary	Quality of Life- Functional Assessment of Cancer Therapy - Prostate cancer (FACT-P)	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.	8 weeks
Secondary	Grip strength	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)	8 weeks
Secondary	Fatigue -Functional assessment of chronic illness therapy - fatigue	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.	8 weeks
Secondary	Sarcopenia Risk Survey	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.	8 weeks
Secondary	Anxiety - The Hospital Anxiety and Depression Scale (HADS)	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.	8 weeks