중증근무력증 환자를 대상으로 저강도와 중강도 운동의 가능성과 건강 영향 비교를 위한 12주간의 시험입니다.

Aerobic intensity levels: Heart rate reserve (HRR) 30-39%, 9-11 Borg Rate of Perceived Exertion (RPE) Strength intensity levels: %One Repetition Max (1RM) 40-50%, OMNI RPE 1-4

12 weeks light intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries. Participants have the intensity goals descripted in the experimental arm.

Light Intensity Exercise

Aerobic intensity levels: HRR 40-59%, 12-13 Borg RPE Strength intensity levels: %1RM 60-80%, OMNI RPE 5-6

12 weeks moderate intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries. Participants have the intensity goals descripted in the experimental arm.

Moderate Intensity Exercise

유산소 운동 강도 수준: 심박수 예비량(HRR) 30-39%, 보그 운동자각도(RPE) 9-11 근력 운동 강도 수준: 1회 최대 반복(1RM)의 % 40-50%, OMNI RPE 1-4

저강도 운동

유산소 운동 강도: 심박수 40-59%, 보그 운동자각도 12-13 근력 운동 강도: 최대 반복 횟수의 60-80%, 옴니 운동자각도 5-6

중강도 운동

Clinical Trial Coordinator

중증근무력증 환자에게 있어 저강도 운동과 중강도 운동의 비교

handgrip and treadmill walking 4 days per week

6 weeks of exercise training (Pre-training)

6 weeks of exercise training (Post-training)

Jill Slade, PhD

Katharine Currie, PhD

All participants will undergo four experimental sessions in a randomized, counterbalanced order: 1) Resting with Placebo; 2) Resting with Nitrate Supplementation; 3) Aerobic Exercise with Placebo; and 4) Aerobic Exercise with Nitrate Supplementation. A washout period of at least 2 days will be respected between sessions.

Participants will ingest 2 capsules of a standardized beetroot extract (Berkeley Life Nitric Oxide Foundation). Each dose provides approximately 314 mg of dietary nitrate.

Beetroot Extract (Nitrate-rich)

Capsules identical in appearance, color, and size to the experimental supplement, but containing an inert substance (starch). This intervention is used to maintain the double-blind design of the study.

Placebo

Participants will perform a single aerobic exercise session on a treadmill. The protocol consists of a 7-minute warm-up followed by 30 minutes of continuous exercise at an intensity corresponding to 60-80% of maximum heart rate (HRmax), estimated using Tanaka's formula (208 - 0.7 \* age). Rate of Perceived Exertion (RPE) will be monitored periodically using the Borg scale (6-20).

Exercise

Participants will remain seated for 30 minutes (matching the exercise session duration). During this time, a researcher will administer a Food Frequency Questionnaire (FFQ) in an interview format. This activity serves to assess dietary habits and simulates a routine, low-exertion daily activity (similar to a conversation), acting as a time-matched control for the exercise session.

Rest (Control Condition)

Anderson S Zago, Professor

Nutritional intervention: Routine postoperative oral nutritional supplements (ONS) will be provided, and patients with metabolic diseases such as diabetes will undergo strict glycemic control. Psychological intervention: Patients with a Hospital Anxiety and Depression Scale (HADS) score ≥ 8 will receive cognitive behavioral therapy (CBT), and those with a HADS score ≥ 11 will be referred for psychological consultation. Exercise intervention: Postoperative rehabilitation training will be guided according to different postoperative periods.

Early structured postoperative intervention encompassing nutrition, psychology, and exercise

Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy.

A procedure to measure how well or poorly your heart is pumping and to measure the pressures in the heart and lungs. A catheter will be inserted into a vein and artery in order to take the measurements and this will be conducted while exercising on a supine cycle ergometer. Various measurements will be taken during periods of rest and exercise.

Right Heart Catheterization (RHC) while exercising

A sample of muscle tissue will be collected and analyzed for the ability of the cells to utilize oxygen.

Optional Muscle Biopsy

Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy.

30mcg (5 breaths) of inhaled treprostinil will be administered during the RHC procedure and patients will be initiated on outpatient inhaled treprostinil therapy for 3-months with gradual up titration to target dose as per standard clinical practice.

Treprostinil

Temporary target during an anaerobic training session

SmartGuard during an anaerobic training session

Maria M Manrique

Ana M Gómez, Endocrinologyst

Receive tele-exercise training and undergo pulmonary function testing and exercise testing

Tele-exercise

The intervention consists of a supervised, in-person, combined exercise program lasting 16 consecutive weeks, conducted at a specialized exercise unit. Participants attend two sessions per week, with at least 48 hours of recovery between sessions, and each session lasts between 55 and 85 minutes. The program follows a "combined" methodology, meaning every session integrates both resistance (strength) and aerobic training. To ensure safety and precision, sessions are led by a graduate in Physical Activity and Sport Sciences with specialized training in oncology, and participants work in small groups of 6 to 8 people.

Each session is structured into four distinct parts: a 10-minute warm-up involving low-to-moderate intensity activity and joint mobility; a resistance training block; an aerobic training block; and a cool-down featuring static stretching for 30-40 seconds per muscle group. The resistance training portion utilizes a "full body" approach.

Participants assigned to the control group receive standard care typically provided to patients in this phase of recovery. Instead of a supervised exercise program, these individuals are sent educational materials via email. This material consists of a video and official documents containing basic guidelines and recommendations for a healthy lifestyle, based on standards from the World Health Organization (WHO) and the American College of Sports Medicine (ACSM) for cancer survivors. The documents provide general instructions on physical activity, reducing sedentary behavior, and maintaining overall health habits. Like the intervention group, participants in the control group undergo all clinical and functional evaluations at the start of the study, after 16 weeks, and during a 3-month follow-up.

Control

Susana Aznar Laín

This group will receive basic body awareness training

Basic body awareness training will be applied to preschool children in terms of motor development and body perception

body awareness therapy

An obstacle course will be set up for this group and play-based exercise methods will be implemented.

Play-based exercise training will be implemented for preschool children by designing games that they enjoy playing, in order to support motor development and body perception.

play-based exercise

harran lecturer

Patients in the conventional rehabilitation group will participate in a rehabilitation program at least 3 days a week, with each session lasting 1.5 hours. The program will include neurophysiological exercises, strengthening exercises, and balance and coordination exercises, performed in three sets of 10 repetitions. There will be warm-up and cool-down periods before and after each session.

: Patients in the conventional rehabilitation group will participate in a rehabilitation program 3 days a week, with each session lasting 1.5 hours. The program will include neurophysiological exercises, strengthening exercises, and balance and coordination exercises, performed in three sets of 10 repetitions. There will be warm-up and cool-down periods before and after each session.

Conventional rehabilitation therapy

This group will take 3 times a week Qi gong therapy with classical conventional therapy.

The protocol includes eight traditional movements, such as:

* Raising Hands to the Sky,
* Drawing the Bow to Hit the Hawk,
* Separating Heaven and Earth,
* The Wise Owl Looking Back,
* Shaking the Head and Tail,
* Bending to Touch the Feet,
* Clenching Fists and Gathering Energy with a Fierce Look,
* Shaking the Body by Hitting the Heels. Each exercise sequence will be performed with warm-up (deep breathing) and cool-down (focusing on energy flow). The Qigong group will participate in a 45-minute additional Qigong session (three times a week), led by a physiotherapist, after their conventional rehabilitation program.

The protocol includes eight traditional movements, such as:

* Raising Hands to the Sky (9 repeats)
* Drawing the Bow to Hit the Hawk (9 left, 9 right repeats)
* Separating Heaven and Earth (9 repeats)
* The Wise Owl Looking Back. (9 left, 9 right repeats)
* Shaking the Head and Tail (9 left, 9 right repeats)
* Bending to Touch the Feet (9 repeats)
* Clenching Fists and Gathering Energy with a Fierce Look (9 left, 9 right repeats)
* Shaking the Body by Hitting the Heels (9 repeats) Each exercise sequence will be performed with warm-up (deep breathing) and cool-down (focusing on energy flow). The Qigong group will participate in a Qigong session 3 days a week,30-45 minutes, led by a physiotherapist, after their conventional rehabilitation program (3 days a week, with each session lasting 1,5 hours).Breathing in and out will be performed in coordination with qigong movements.

Qi gong Baduanjin Exercises

Intervention group that receive 30 min exercise training twice weekly in 20 weeks

Exercise training with aerobic and strength training, 30 min per session

Exercise training

Stig Molsted, PhD

Stig Moelsted, PhD

Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.

Biospecimen Collection

Educational Intervention

Fisetin

Physical Performance Testing

Quality-of-Life Assessment

Questionnaire Administration

Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.

Receive individually tailored exercise intervention

Exercise Intervention

Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.

Placebo Administration

Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.

Mina S. Sedrak, MD

Mina S. Sedrak

Mina S. sedrak, MD

Participants within the experimental arm will participate in the co-designed, pre-radiotherapy exercise programme alongside treatment.

Participants will participate in twenty, supervised exercise sessions, performed within the radiotherapy department, immediately before treatment. Each session has a 20 minute duration at one of four exercise intensity levels based on the participants baseline assessment results, and preferences.

Participants involved in this study will receive 55 Gray (Gy) of radiotherapy only, administered in twenty fractions as per standard treatment pathways within the trust

radiotherapy

Matthew Peter Beggs, MSc, BSc

Cathryn Dr Crockett, Consultant Clinical Oncologist

All participants will complete one, 60-minute bout of stationary cycling

Exercise Mode

All participants will complete one, 60-minute bout of treadmill walking

4 mg qd titrated to 8 mg qd perindopril + aerobic exercise

Twice weekly centered based aerobic exercise + 3/week home-based walking

Aerobic exercise

Perindopril

50 mg qd titrated to 100 mg qd losartan + aerobic exercise

Losartan

12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise

HCTZ

Home-based relaxation therapy using a Virtual Reality system with a via guided breathing exercise application.

Home-based guided breathing exercise using a virtual reality system application.

Virtual Reality Guided Breathing Exercise

Persons with ALS will be monitored with the same outcome measures as the intervention group, but no intervention will be provided.

Patients and caregivers receive Walking for Recovery from Surgery prehabilitation intervention in 4 sessions 3-7 days before surgery, before discharge, and at 2 and 7 days post-discharge.

Receive Walking for Recovery from Surgery prehabilitation intervention

Survey Administration

Participants will be given general recommendations to increase physical activity and improve nutrition before surgery.

Participants will receive general recommendations to maintain physical activity.

Enhanced Usual Care

Participants will take part in a monitored exercise program. The study team will provide more instructions and information about the program

Participants will take part in a monitored exercise program.

Tele-supervised resistance exercises

Patients will receive a selected physical therapy program only.

Patients will receive a selected physical therapy program for 1 hr, 3 times per week, for 3 successive months in the form of:

* Balance and postural control exercises for 15 minutes, including the following:

  * Standing on balance board.
  * Stoop and recovery.
* Gait training for 45 minutes, including the following:

  * Forward, backward, and sideways walking.
  * Walking with obstacles using wedges and rolls with different diameters and heights.

Selected physical therapy program

Patients will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training.

Patients will receive the same selected physical therapy program as the control group for 15 minutes in addition to treadmill training for 45 minutes, 3 times per week, for 3 successive months.

Treadmill training: Will be practiced according to the following stages:

A- Warm up: 5 minutes.

B- The exercise phase: 35 minutes (three-minute stages), the speed will be increased gradually every 3 minutes intervals until the child no longer be able to walk at the current stage.

C- Cool down: 5 minutes.

중증근무력증 환자에게 있어 저강도 운동과 중강도 운동의 비교

6주간의 운동 훈련(Pre-training), 6주간의 운동 훈련(Post-training)

비트루트 추출물(질산염 함유), 위약, 운동, 휴식(대조군)

영양, 심리 및 운동을 포함하는 조기 구조화된 수술 후 중재

트레프로스티닐, 운동 중 우심장 카테터 도관술(RHC), 선택적 근육 생검

무산소 운동 훈련 세션 중 임시 목표, 무산소 운동 훈련 세션 중 SmartGuard

원격 운동

통제, 운동

신체 인식 치료, 놀이 기반 운동

전통 재활 치료, 기공 팔단금 운동

운동 훈련

운동

생체 시료 채취, 교육적 중재, 운동 중재, 피세틴, 신체 성능 검사, 위약 투여, 삶의 질 평가, 설문지 투여

운동, 방사선 치료

운동 모드

유산소 운동, 페린도프릴, 로사르탄, HCTZ

가상현실을 활용한 호흡 운동

운동 중재, 삶의 질 평가, 설문 조사 관리

강화된 일반 치료, 원격 감독 하의 저항 운동

선택된 물리 치료 프로그램, 유산소 운동