Evaluation the Effect of 8 Weeks Respiratory Muscle Training on Respiratory Capacity, Functional Capacity and Quality of Life on Subjects with Mild to Moderate Relapsing Remitting Multiple Sclerosis

The purpose of the present study is to examine the influence of 8 weeks of respiratory muscle training on pulmonary function and respiratory muscle strength in MS patients.

A controlled clinical trial with parallel, double-blind, randomized groups on 36 patients with MS. computer-generated randomization was used for randomization.

It will be conducted on 36 patients with MS who will be referred by a neurologist at Sina Hospital. Patients are divided into two groups by computer randomization. A researcher who is not involved in any other part of the study assigns them to two groups.

Inclusion criteria are patients over 18 years of age, with a definitive diagnosis of relapsing-remitting MS that at least one year has passed since the diagnosis, patients are able to walk, have no relapse in a recent month, and have not received corticosteroid pulses in the last month. Exclusion criteria include patients with a history of any respiratory disease, or have an active pulmonary infection and will also be excluded from the study if they have contraindications to do aerobic activities (such as orthopedic and muscular problems), smoker, pregnancy, and participating in another research program.

The intervention group will be educated exercises with a pressure threshold device (Power-breath), then patients will do exercises for 8 weeks. Patients will be followed up by telephone and the intensity of the device will be increased on a weekly basis. After 4 weeks, patients will be re-visited and side effects will be recorded. The control group will be explained only the training and importance of regular physical activity in MS patients and lifestyle modification, and both groups will be given a booklet in this regard.

PImax; PEmax; 6MWT; TUG test; quality of life; and spirometric parameters

Patients are allocated to two groups by computer-generated randomization in blocks of 36 in a 1:1 ratio. The patients are randomized to 1 of 2 groups: the intervention group (RMT) and the control group. A research assistant not involved in any other part of the study will open the sealed opaque envelopes and assign the patients to their respective treatment groups.

The assessor is a sports medicine specialist who is blinded to dividing the groups of patients. Moreover, the results will also be analyzed by a statistical researcher, that is blinded to dividing the groups of patients. Teaching respiratory muscle exercises to the intervention group as well as explaining the general exercise training booklet in both groups is done by a sports medicine specialist who is not involved in patient evaluation.

Specific participant data sets are to be shared (e.g., all collected deidentified IPD, IPD collected for the primary outcome measure only, etc).

starting immediately after publication

information/documents are available for people working in academic institutions and also people working in businesses.

For use in meta-analysis studies or systematic review articles

Shima Ghannadi. Sports Medicine Research Center. No 7, Al-e-Ahmad Highway, Tehran, IR Iran. Email Address: Sh_ghannadi90@yahoo.com

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