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Effects of Exercise Training on Muscle Strength and Aerobic Capacity in Patients with Amyotrophic Lateral Sclerosis

Tailored Exercise Training as a New Intervention to Counteract Muscle Disuse in Patients with Amyotrophic Lateral Sclerosis: Effects on Muscle Strength and Aerobic Capacity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001244392
Acronym
TRAIN-ALS
Enrollment
13
Registered
2017-08-25
Start date
2018-05-21
Completion date
2025-12-23
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Amyotrophic Lateral Sclerosis (ALS) is a devastating disease, characterised by a progressive degeneration and loss of motor neurons, and is currently incurable. The reduction or avoidance of physical activity by patients with ALS (pALS) exacerbates the loss of physical function attributable to the disease itself, and sets up a deleterious cycle of progressive impairment. One potential way to break this cycle is exercise. The main aim of this proposal is to provide the first physiological evidence of the beneficial effect of exercise training in pALS, by counteracting the muscle weakness, due to cardiovascular deconditioning and muscle disuse, caused by the avoidance or reduction of physical activity in these patients. Our primary hypothesis is that involvement in a moderate-intensity, aerobic and strength training program will be tolerated and will attenuate reductions in physical performance (muscle strength and aerobic capacity) and physical function in pALS, and will consequently improve their quality of life. If the proposed hypothesis is confirmed, this study will change the role of physical activity in the clinical management and treatment of pALS.

Interventions

Participants in the study will be randomised in 2 groups: the training group (TRAIN) and the control group (CTRL). TRAINING GROUP - TRAIN Patients in TRAIN will visit the Victoria University Clinical Exercise Rehabilitation Clinic, Footscray Park Campus, Footscray (VIC), 3 times a week for 12 weeks. The training will be supervised by medical doctors specialized in Sports Medicine and Neurology, Exercise Physiologists and Students in the Master of Clinical Exercise and Rehabilitation at Victoria

Participants in the study will be randomised in 2 groups: the training group (TRAIN) and the control group (CTRL). TRAINING GROUP - TRAIN Patients in TRAIN will visit the Victoria University Clinical Exercise Rehabilitation Clinic, Footscray Park Campus, Footscray (VIC), 3 times a week for 12 weeks. The training will be supervised by medical doctors specialized in Sports Medicine and Neurology, Exercise Physiologists and Students in the Master of Clinical Exercise and Rehabilitation at Victoria University. The training will be fully supervised with a patient/therapist ratio of 1:1. Each session, of 1 h duration, will be characterised by: - 15 min of cycling at moderate intensity, e.g. at 50% of maximal aerobic capacity (VO2peak); - 25 min of strength exercises at 60% of 1 repetition maximum (extrapolated from the 10RM test). One set of 10 repetitions of upper and lower body exercises on isotonic machines will be realised; - 10 min of balance exercises; - 10 min of stretching exercises. Following the ability of each patient, the training will be adapted in the best way to him. The exercise physiologists will be able to adapt the exercises following the ability of the patients, but maintaining the scope (i.e. ameliorate the strength of a specific muscle group) and the quantity and intensity of the specific exercise. In fact, because the intensity of the training is relative, all patients will realise the same percentage of their maximal strength or aerobic capacity. The adherence to the training program will be assessed by the investigators at the end of the 12 weeks of training. It will be explained to the patients before their consent, the importance of their participation to the training session for the outcomes of this study. The day and time of the training session will be decided together with the patient and it will be given to the patients the maximal possible freedom in the choice of the time of the day/day of the week for training. It will be asked to the patients to communicate to the exercise physiologist if they cannot participate to the training session and if they wish to communicate also the reason of their absence. Each participant will perform 6 test sessions (test 1, test 2 and test 3): 3 before and 3 after 12 weeks of training. Test 1 will be performed at Sunshine Hospital, St Albans (VIC), and Test 2 and 3 at Victoria University, Footscray Park, Footscray (VIC). All testing sessions will be supervised at least by a medical doctor and an exercise physiologist. Test 1. A medical doctor will administrate to the participants the ALSFRS-R scale and McGill Quality of Life and Brief Pain Inventory questionnaires. Successively, the patients will perform a cardiopulmonary exercise testing on a cycle ergometer, under medical supervision and with 12-lead electrocardiography monitoring. A small probe will be positioned on the belly of the vastus lateralis muscle to evaluate the maximal capacity of the muscle to extract O2 by Near-Infrared Spectroscopy (NIRS). Blood lactate will be determined on capillary blood samples obtained from an ear lobe, at rest and at 1, 3, 5 and 7 min after the termination of the maximal exercise. At the end of the exercise, a transient leg ischemia will be also performed by pressure cuff inflation (at about 300 mmHg) at the base of the thigh, for a few minutes (3-5 min). Test 2: Patients will return to the laboratory to perform the "Timed Up and Go" test, a measure of functional capacity that incorporates balance, strength and mobility. Successively, the patients will perform the 10 repetitions maximum (10RM) test, to assess the strength of some lower and upper body muscle groups. 10RM is defined as the load that the subject is able to lift no more than 10 times. Test 3. Patients will perform the "6 minutes walking test". Successively, the patients will perform the 10 repetitions maximum (10RM) test, to assess the strength of the remaining lower and upper body muscle groups. The electromyographyc activity of the abductor pollicis will be also evaluated. The 10RM will be also evaluated after 6 weeks of training, and the weight lifted by patients during training will be recalculated.

Sponsors

Alessandra Ferri
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Patients with definite, probable or possible amyotrophic lateral sclerosis (based on El Escorial Criteria) - Age: >18 years old - Patients able to understand and comply with the requirements of the entire study (i.e. cycle on a bicycle), and to give an informed consent

Exclusion criteria

- Any medical disorder that would make physical activity contraindicated, including active malignancy, severe heart, lung, renal and liver failure - Women who are pregnant or breastfeeding - Participation in pharmacological studies within the last 30 days before screening

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026