NCT06145243

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

November 16, 2023

Last Update Submit

July 18, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

  • Muscle strength

    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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Grip strength

    8 weeks

  • Fatigue -Functional assessment of chronic illness therapy - fatigue

    8 weeks

  • Sarcopenia Risk Survey

    8 weeks

  • Anxiety - The Hospital Anxiety and Depression Scale (HADS)

    8 weeks

Study Arms (3)

Visual brochure based resistive home exercise group,

ACTIVE COMPARATOR

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

Video-based resistive home exercise group

ACTIVE COMPARATOR

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

Supervised resistance exercise group

EXPERIMENTAL

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

Interventions

Home based exerciseOTHER

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.

Visual brochure based resistive home exercise group,
Video-based resistive exerciseOTHER

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.

Video-based resistive home exercise group
Supervised resistive exerciseOTHER

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.

Supervised resistance exercise group

Eligibility Criteria

Age65 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professor Cemil Taşcıoğlu Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 24, 2023

Study Start

October 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 15, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations

TU(1)