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

July 18, 2024 updated by: Özlem Feyzioğlu, Acibadem University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Professor Cemil Taşcıoğlu Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Visual brochure based resistive home exercise group,
In the 8-week exercise training, the exercise resistance of the patients will start with 60-70% according to1 Repetition Maximum in the first 4 weeks and will be increased to 70-80% according to 1 Repetition Maximum in the last 4 weeks according to the American College of Sports Medicine safe exercise intensity guideline for elderly individuals.
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.
Active Comparator: Video-based resistive home exercise group
In the 8-week exercise training, the exercise resistance of the patients will start with 60-70% according to 1 Repetition Maximum in the first 4 weeks and will be increased to 70-80% according to 1 1 Repetition Maximum in the last 4 weeks according to the American College of Sports Medicine safe exercise intensity guideline for elderly individuals.
Other: 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.
Experimental: Supervised resistance exercise group
In the 8-week exercise training, the exercise resistance of the patients will start with 60-70% according to 1 Repetition Maximum in the first 4 weeks and will be increased to 70-80% according to 1 Repetition Maximum in the last 4 weeks according to the American College of Sports Medicine safe exercise intensity guideline for elderly individuals.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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.
8 weeks
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.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks
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.
8 weeks
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.
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK 2023-10/342

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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