NCT05332171

Brief Summary

Cancer treatments usually include surgery, chemotherapy, radiation therapy, hormone therapy, and/or a combination of these methods. These treatments cause many physical and psychological effects that interfere with functional independence, performing activities of daily living, and healthy quality of life. Mostly, depending on cancer and its treatment; Cognitive function, sleep pattern, functional capacity, pain state and bone mineral density are affected. Exercise compliance is the degree to which an individual's behavior is consistent with the health care provider's advice and treatment plan. According to the World Health Organization, compliance is "a measure of a person's behavior (such as following a recommended exercise program, monitoring drug intake, etc.). ) as a response to complying with recommendations deemed appropriate by health care professionals''. In the field of rehabilitation too, compliance is increasingly used in relation to the self-management of patients' health. It has been stated in the studies that the level of compliance with the recommended home exercise is generally low, which limits the benefits of exercise programs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

April 5, 2022

Last Update Submit

April 12, 2022

Conditions

Keywords

Lung CancerPulmonary Rehabilitationcalisthenic exerciseexercise adherence

Outcome Measures

Primary Outcomes (1)

  • Exercise compliance of patients with lung cancer who are given calisthenic exercise increases

    Exercise compliance increases in patients who are given calisthenic exercises accompanied by a physiotherapist.

    8 week

Secondary Outcomes (1)

  • The functional capacity of patients with lung cancer who are given calisthenic exercise increases.

    8 week

Study Arms (2)

physical activity counseling

NO INTERVENTION

Home exercises will be taught to the physical activity counseling group and will be followed up under the supervision of a physiotherapist with weekly controls. Evaluation will be done before and after treatment.

training group

ACTIVE COMPARATOR

Breathing exercises and calisthenic exercises will be taught to the training group, and they will be followed under the supervision of a physiotherapist for 8 weeks, 3 days a week. Evaluations will be made before and after treatment. Individuals in the calisthenic exercise group will be given exercise training at the level of 65%-80% of the maximal heart rate for 30-40 minutes, 3 days a week for 8 weeks.

Behavioral: Pyhsiohterapy and rehabilitation

Interventions

Before starting the exercise program, 10 repetitive warm-up exercises will be given including the lower and upper extremities and distal joints. The exercises will be started with 5 repetitions in the first week. Depending on the patient's tolerance, the intensity of the exercise will be increased as 10 repetitions, 15 repetitions and 20 repetitions, and optional rest will be allowed between exercises. It is aimed that the patients reach 20 repetitions in the 6th week at the latest.

training group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients whose chemotherapy and radiotherapy has ended, at least 6 months and maximum 5 years after surgery
  • Being between the ages of 18-65
  • and 5 years according to the Modified Borg Scale Patients with severe fatigue

You may not qualify if:

  • Uncontrollable hypertension, diabetes mellitus, heart failure and atrial fibrillation
  • Any acute infection during the evaluation
  • Orthopedic, neurological, psychological, etc., which will limit the evaluations. with problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu Univercity

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It is aimed to evaluate patients with Lung Cancer who meet the inclusion criteria of the study. Individuals will be randomly assigned to physical activity counseling and training groups. The number of participants in the groups will be determined by power analysis. Criteria for inclusion in the study; * Patients whose chemotherapy and radiotherapy has ended, at least 6 months and maximum 5 years after surgery * Being between the ages of 18-65 * 3 and 5 years according to the Modified Borg Scale Patients with severe fatigue Exclusion criteria; * Uncontrollable hypertension, diabetes mellitus, heart failure and atrial fibrillation * Any acute infection during the evaluation * Orthopedic, neurological, psychological, etc., which will limit the evaluations. with problems
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 18, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Locations